<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/NCT02247531</url>
  </required_header>
  <id_info>
    <org_study_id>GX29185</org_study_id>
    <secondary_id>2014-000106-35</secondary_id>
    <nct_id>NCT02247531</nct_id>
  </id_info>
  <brief_title>A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration</brief_title>
  <acronym>SPECTRI</acronym>
  <official_title>A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled&#xD;
      study evaluating the efficacy and safety of lampalizumab administered by intravitreal&#xD;
      injections in participants with geographic atrophy (GA) secondary to age-related macular&#xD;
      degeneration (AMD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">October 6, 2014</start_date>
  <completion_date type="Actual">January 23, 2018</completion_date>
  <primary_completion_date type="Actual">January 23, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48</measure>
    <time_frame>Baseline, Week 48</time_frame>
    <description>The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48</measure>
    <time_frame>Baseline, Week 48</time_frame>
    <description>For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48</measure>
    <time_frame>Baseline, Week 48</time_frame>
    <description>Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48</measure>
    <time_frame>Baseline, Week 48</time_frame>
    <description>Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48</measure>
    <time_frame>Baseline, Week 48</time_frame>
    <description>BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48</measure>
    <time_frame>Baseline, Week 48</time_frame>
    <description>The low luminance visual acuity was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. A negative change from baseline indicates a decrease in the visual acuity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48</measure>
    <time_frame>Baseline, Week 48</time_frame>
    <description>MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48</measure>
    <time_frame>Baseline, Week 48</time_frame>
    <description>MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48</measure>
    <time_frame>Baseline, Week 48</time_frame>
    <description>NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health, general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale or total score is the average of items contributing to the score. For each subscale and total score the score range is 0 to 100 with a higher score representing better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48</measure>
    <time_frame>Baseline, Week 48</time_frame>
    <description>NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48</measure>
    <time_frame>Baseline, Week 48</time_frame>
    <description>NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48</measure>
    <time_frame>Baseline, Week 48</time_frame>
    <description>The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">975</enrollment>
  <condition>Geographic Atrophy</condition>
  <arm_group>
    <arm_group_label>Lampalizumab once in every 4 weeks (Q4W)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 10 mg (milligrams) dose of lampalizumab by intravitreal injection, Q4W, starting at the Day 1 visit for approximately 92 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lampalizumab once in every 6 weeks (Q6W)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 10 mg dose of lampalizumab by intravitreal injection, Q6W, starting at the Day 1 visit for approximately 90 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Comparator</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will receive sham comparator, Q4W, starting at the Day 1 visit for approximately 92 weeks or Q6W, starting at the Day 1 visit for approximately 90 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lampalizumab</intervention_name>
    <description>10 mg dose of lampalizumab administered intravitreally.</description>
    <arm_group_label>Lampalizumab once in every 4 weeks (Q4W)</arm_group_label>
    <arm_group_label>Lampalizumab once in every 6 weeks (Q6W)</arm_group_label>
    <other_name>RO5490249</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Comparator</intervention_name>
    <description>A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.</description>
    <arm_group_label>Sham Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants aged greater than or equal to (&gt;/=) 50 years&#xD;
&#xD;
          -  Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular&#xD;
             Degeneration (AMD) with no evidence of prior or active choroidal neovascularization&#xD;
             (CNV) in both eyes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Ocular Exclusion Criteria (Study Eye):&#xD;
&#xD;
          -  History of vitrectomy surgery, submacular surgery, or other surgical intervention for&#xD;
             AMD&#xD;
&#xD;
          -  Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein&#xD;
             occlusion, and proliferative diabetic retinopathy&#xD;
&#xD;
          -  Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection,&#xD;
             anti-angiogenic drugs, anti-complement agents, or device implantation)&#xD;
&#xD;
        Ocular Exclusion Criteria (Both Eyes):&#xD;
&#xD;
          -  GA in either eye due to causes other than AMD&#xD;
&#xD;
          -  Previous treatment with eculizumab, lampalizumab, and/or fenretinide&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Associated Retina Consultants</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Associates Southwest PC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85750</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Orange County</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSD Shiley Eye Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093-0946</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jules Stein Eye Institute/ UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095-7000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N CA Retina Vitreous Assoc</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Byers Eye Insitute at Stanford</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants, San Diego</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <zip>92064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Davis, Eye Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retinal Consultants Med Group</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95841</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Retina Consultants</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Retina Associates</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Southern</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Retina Associates, PC</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Retina Associates</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Group of New England</name>
      <address>
        <city>Waterford</city>
        <state>Connecticut</state>
        <zip>06385</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Group of Florida</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Health Center</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bascom Palmer Eye Institute</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Vitreous Assoc of FL</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Vitreoretinal Assoc</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wolfe Eye Clinic</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitreo Retinal Consultants</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paducah Retinal Center</name>
      <address>
        <city>Paducah</city>
        <state>Kentucky</state>
        <zip>42001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Retina Care Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilmer Eye Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Group of Washington</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Specialists</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mass Eye and Ear Infirmary</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan, Kellogg Eye Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kresge Eye Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201-1423</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitreoretinal Surgery</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Vision Research Foundation</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNMC Truhlsen Eye Institute</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sierra Eye Associates</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Atlantic Retina - Wills Eye Hospital</name>
      <address>
        <city>Cherry Hill</city>
        <state>New Jersey</state>
        <zip>08034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retinal &amp; Ophthalmic Cons PC</name>
      <address>
        <city>Northfield</city>
        <state>New Jersey</state>
        <zip>08225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Associates of NJ</name>
      <address>
        <city>Teaneck</city>
        <state>New Jersey</state>
        <zip>07666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Weil Cornell Med Ctr</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitreous-Retina-Macula</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Assoc of Western NY</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Carolina Retinal Associate PA</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Char Eye Ear &amp;Throat Assoc</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Eye Center; Vitreoretinal</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Eye Institute</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OSU Eye Physicians &amp; Surgeons</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina &amp; Vitreous Center of Southern Oregon</name>
      <address>
        <city>Ashland</city>
        <state>Oregon</state>
        <zip>97520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Northwest</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon HSU; Casey Eye Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Atlantic Retina</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny Ophthalmic &amp; Orbital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MUSC Storm eye institute</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmetto Retina Center</name>
      <address>
        <city>Florence</city>
        <state>South Carolina</state>
        <zip>29501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Neuroscience Inst</name>
      <address>
        <city>Ladson</city>
        <state>South Carolina</state>
        <zip>29456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Black Hills Eye Institute</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Retina Associates Chattanooga</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charles Retina Institution</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Res Institute of Texas</name>
      <address>
        <city>Abilene</city>
        <state>Texas</state>
        <zip>79606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Retina Associates</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scott and White Hospital</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Houston</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ of Virginia Ophthalmology</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitreoretinal Associates of Washington</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oftalmos</name>
      <address>
        <city>Capital Federal</city>
        <zip>C1120AAN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de la Vision</name>
      <address>
        <city>Capital Federal</city>
        <zip>C1122AAI</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital El Cruce</name>
      <address>
        <city>Florencio Varela</city>
        <zip>B1888AAE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queensland Eye Institute</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adelaide Eye and Retina Centre</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vision Eye Institute Eastern</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victorian Eye and Ear Hospital</name>
      <address>
        <city>East Melbourne</city>
        <state>Victoria</state>
        <zip>3002</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Lions Eye Institute</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Brugmann (Victor Horta)</name>
      <address>
        <city>Bruxelles</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven Sint Rafael</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37</name>
      <address>
        <city>Glostrup</city>
        <zip>2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Pellegrin; Ophtalmologie</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bocage; Ophtalmologie</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la croix rousse; Ophtalmologie</name>
      <address>
        <city>Lyon cedex</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Paradis Monticelli; Ophtalmologie</name>
      <address>
        <city>Marseille</city>
        <zip>13008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHNO des Quinze Vingts; Ophtalmologie</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Freiburg, Klinik für Augenheilkunde</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Heidelberg; Augenklinik</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik</name>
      <address>
        <city>Ludwigshafen</city>
        <zip>67063</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMU Klinikum der Universität, Augenklinik</name>
      <address>
        <city>München</city>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der TU München; Augenklinik</name>
      <address>
        <city>München</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Regensburg, Klinik &amp; Poliklinik für Augenheilkunde</name>
      <address>
        <city>Regensburg</city>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR</name>
      <address>
        <city>Budapest</city>
        <zip>1076</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem AOK, Szemeszeti Klinika</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ganglion Medial Center</name>
      <address>
        <city>Pécs</city>
        <zip>7621</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA</name>
      <address>
        <city>Genova</city>
        <state>Liguria</state>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irccs Ospedale San Raffaele;U.O. Oculistica</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20157</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica</name>
      <address>
        <city>Firenze</city>
        <state>Toscana</state>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica</name>
      <address>
        <city>Udine</city>
        <state>Veneto</state>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nuestra Señora de La Luz</name>
      <address>
        <city>Mexico City</city>
        <zip>06030</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Monterrey</name>
      <address>
        <city>Monterrey</city>
        <zip>64040</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Mexicano de Oftalmologia I.A.P.</name>
      <address>
        <city>Querétaro</city>
        <zip>76090</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboud University Nijmegen Medical Centre; Ophthalmology</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525 EX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medisch Centrum</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mácula D&amp;T</name>
      <address>
        <city>Lima</city>
        <zip>27</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Laser Oftalmica</name>
      <address>
        <city>Lima</city>
        <zip>27</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion Oftalmolaser</name>
      <address>
        <city>Lima</city>
        <zip>33</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OFTALMIKA Sp. z o.o</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-631</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny nr 1; Oddzial Okulistyki</name>
      <address>
        <city>Bytom</city>
        <zip>41-902</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny; Klinika Okulistyki</name>
      <address>
        <city>Wrocław</city>
        <zip>50-556</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Okulistyczna Jasne Błonia</name>
      <address>
        <city>Łódź</city>
        <zip>91-134</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AIBILI - Association for Innovation and Biomedical Research on Light</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-548</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Espaco Medico Coimbra</name>
      <address>
        <city>Coimbra</city>
        <zip>3030-163</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Santa Maria; Servico de Oftalmologia</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Sao Joao; Servico de Oftalmologia</name>
      <address>
        <city>Porto</city>
        <zip>4200-319</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SAHI &quot;Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic&quot;</name>
      <address>
        <city>Kazan</city>
        <zip>420012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI &quot;Scientific Research Institute of Eye Diseases&quot; of Russian Academy of medical Sciences</name>
      <address>
        <city>Moscow</city>
        <zip>119435</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Educ.Inst. of High Prof.Education &quot;Samara State Medical University&quot;; Chair of ophathalmology</name>
      <address>
        <city>Samara</city>
        <zip>443068</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU</name>
      <address>
        <city>Banska Bystrica</city>
        <zip>975 17</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB</name>
      <address>
        <city>Bratislava</city>
        <zip>851 07</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Oftalmologico Gomez Ulla</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>LA Coruña</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universitaria de Navarra; Servicio de Oftalmologia</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Perpetuo Socorro; Servicio de Oftalmología</name>
      <address>
        <city>Albacete</city>
        <zip>02006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de microcirugia ocular</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VISSUM Madrid Santa Hortensia</name>
      <address>
        <city>Madrid</city>
        <zip>28002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario la Fe: Servicio de Oftalmologia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Eriks Eye Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>SE-112 82</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital Bern, Universitätsklinik für Augenheilkunde</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vista Klinik Binningen</name>
      <address>
        <city>Binningen</city>
        <zip>4102</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe University Medical Faculty; Department of Ophthalmology</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara University Medical Faculty; Department of Ophthalmology</name>
      <address>
        <city>Ankara</city>
        <zip>06340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara Baskent University Medical Faculty; Department of Ophthalmology</name>
      <address>
        <city>Ankara</city>
        <zip>06490</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul University Istanbul Medical Faculty; Department of Ophthalmology</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ege University Medical Faculty; Department of Ophthalmology</name>
      <address>
        <city>Izmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokuz Eylul University Medical Faculty; Department of Ophthalmology</name>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Hospital</name>
      <address>
        <city>Belfast</city>
        <zip>BT12 6BA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradford Royal Infirmary</name>
      <address>
        <city>Bradford</city>
        <zip>BD9 6RJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Eye Hospital</name>
      <address>
        <city>Bristol</city>
        <zip>BS1 2LX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gloucestershire Hospitals NHS Foundation Trust</name>
      <address>
        <city>Gloucestershire</city>
        <zip>GL1 3NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre</name>
      <address>
        <city>Liverpool</city>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moorfields Eye Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>EC1V 2PD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macular Treatment Centre; Royal Eye Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillingdon Hospital</name>
      <address>
        <city>Middx</city>
        <zip>UB8 3NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Infirmary</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southampton General Hospital</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Wolverhampton Hospitals NHS Trust</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The York Hospital</name>
      <address>
        <city>York</city>
        <zip>YO31 8HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Peru</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
    <country>Canada</country>
  </removed_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>January 17, 2019</results_first_submitted>
  <results_first_submitted_qc>February 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 14, 2019</results_first_posted>
  <disposition_first_submitted>August 14, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>August 14, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 16, 2018</disposition_first_posted>
  <last_update_submitted>October 14, 2019</last_update_submitted>
  <last_update_submitted_qc>October 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Geographic Atrophy</mesh_term>
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 24, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT02247531/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, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT02247531/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 975 participants were randomized to the study at 144 study sites across 22 countries. The study was terminated early by the Sponsor due to lack of efficacy.</recruitment_details>
      <pre_assignment_details>This study enrolled participants with bilateral Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) and no signs of prior or active choroidal neovascularization (CNV), age &gt;= 50 years with a valid complement factor I (CFI)-profile biomarker result.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sham Comparator</title>
          <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
        </group>
        <group group_id="P2">
          <title>Lampalizumab Q4W</title>
          <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
        </group>
        <group group_id="P3">
          <title>Lampalizumab Q6W</title>
          <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="321"/>
                <participants group_id="P2" count="330"/>
                <participants group_id="P3" count="324"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="215"/>
                <participants group_id="P2" count="205"/>
                <participants group_id="P3" count="214"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="125"/>
                <participants group_id="P3" count="110"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="25"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="66"/>
                <participants group_id="P3" count="62"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unspecified Reason</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) population included all participants who were randomized to the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Sham Comparator</title>
          <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
        </group>
        <group group_id="B2">
          <title>Lampalizumab Q4W</title>
          <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
        </group>
        <group group_id="B3">
          <title>Lampalizumab Q6W</title>
          <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</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="321"/>
            <count group_id="B2" value="330"/>
            <count group_id="B3" value="324"/>
            <count group_id="B4" value="975"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="321"/>
                    <count group_id="B2" value="330"/>
                    <count group_id="B3" value="324"/>
                    <count group_id="B4" value="975"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77.6" spread="8.3"/>
                    <measurement group_id="B2" value="77.3" spread="7.8"/>
                    <measurement group_id="B3" value="78.7" spread="8.0"/>
                    <measurement group_id="B4" value="77.9" spread="8.1"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="321"/>
                    <count group_id="B2" value="330"/>
                    <count group_id="B3" value="324"/>
                    <count group_id="B4" value="975"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="191"/>
                    <measurement group_id="B2" value="197"/>
                    <measurement group_id="B3" value="190"/>
                    <measurement group_id="B4" value="578"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="134"/>
                    <measurement group_id="B4" value="397"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="321"/>
                    <count group_id="B2" value="330"/>
                    <count group_id="B3" value="324"/>
                    <count group_id="B4" value="975"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="298"/>
                    <measurement group_id="B2" value="310"/>
                    <measurement group_id="B3" value="297"/>
                    <measurement group_id="B4" value="905"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Stated</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="321"/>
                    <count group_id="B2" value="330"/>
                    <count group_id="B3" value="324"/>
                    <count group_id="B4" value="975"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="306"/>
                    <measurement group_id="B2" value="315"/>
                    <measurement group_id="B3" value="315"/>
                    <measurement group_id="B4" value="936"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiple</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF)</title>
          <description>At baseline the area of GA was assessed by FAF.</description>
          <units>millimeter square (mm^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="321"/>
                    <count group_id="B2" value="330"/>
                    <count group_id="B3" value="324"/>
                    <count group_id="B4" value="975"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.554" spread="3.983"/>
                    <measurement group_id="B2" value="8.308" spread="3.916"/>
                    <measurement group_id="B3" value="8.498" spread="4.260"/>
                    <measurement group_id="B4" value="8.123" spread="4.071"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry</title>
          <description>Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center.</description>
          <population>The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization).</population>
          <units>number of absolute scotomatous points</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="48"/>
                    <count group_id="B2" value="58"/>
                    <count group_id="B3" value="55"/>
                    <count group_id="B4" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.2" spread="13.5"/>
                    <measurement group_id="B2" value="28.2" spread="17.3"/>
                    <measurement group_id="B3" value="27.9" spread="14.4"/>
                    <measurement group_id="B4" value="26.6" spread="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Macular Sensitivity as Assessed by Mesopic Microperimetry</title>
          <description>Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center.</description>
          <population>The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization).</population>
          <units>decibel (dB)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="48"/>
                    <count group_id="B2" value="57"/>
                    <count group_id="B3" value="54"/>
                    <count group_id="B4" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.5" spread="3.3"/>
                    <measurement group_id="B2" value="5.7" spread="3.8"/>
                    <measurement group_id="B3" value="5.3" spread="3.2"/>
                    <measurement group_id="B4" value="5.8" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study</title>
          <description>BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).</description>
          <population>ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.</population>
          <units>letters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="319"/>
                    <count group_id="B2" value="330"/>
                    <count group_id="B3" value="321"/>
                    <count group_id="B4" value="970"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.1" spread="9.8"/>
                    <measurement group_id="B2" value="66.0" spread="9.6"/>
                    <measurement group_id="B3" value="65.7" spread="9.8"/>
                    <measurement group_id="B4" value="66.0" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions</title>
          <description>The LLVA was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes.</description>
          <population>ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.</population>
          <units>letters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="310"/>
                    <count group_id="B2" value="322"/>
                    <count group_id="B3" value="310"/>
                    <count group_id="B4" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.8" spread="16.5"/>
                    <measurement group_id="B2" value="36.1" spread="17.5"/>
                    <measurement group_id="B3" value="35.8" spread="16.8"/>
                    <measurement group_id="B4" value="36.2" spread="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test or Radner Reading Charts</title>
          <description>Minnesota Low-Vision Reading (MNRead) acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors.</description>
          <population>ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.</population>
          <units>words per minute (wpm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="298"/>
                    <count group_id="B2" value="303"/>
                    <count group_id="B3" value="302"/>
                    <count group_id="B4" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="105.16" spread="56.94"/>
                    <measurement group_id="B2" value="104.38" spread="54.35"/>
                    <measurement group_id="B3" value="99.75" spread="56.56"/>
                    <measurement group_id="B4" value="103.09" spread="55.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts</title>
          <description>MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors.</description>
          <population>ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.</population>
          <units>wpm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="300"/>
                    <count group_id="B2" value="310"/>
                    <count group_id="B3" value="304"/>
                    <count group_id="B4" value="914"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81.20" spread="57.48"/>
                    <measurement group_id="B2" value="80.38" spread="53.70"/>
                    <measurement group_id="B3" value="74.52" spread="50.11"/>
                    <measurement group_id="B4" value="78.70" spread="53.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score</title>
          <description>NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health,general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning.</description>
          <population>ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="283"/>
                    <count group_id="B2" value="299"/>
                    <count group_id="B3" value="296"/>
                    <count group_id="B4" value="878"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.84" spread="15.80"/>
                    <measurement group_id="B2" value="62.88" spread="17.50"/>
                    <measurement group_id="B3" value="64.03" spread="17.65"/>
                    <measurement group_id="B4" value="63.90" spread="17.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NEI VFQ-25 Near Activity Subscale Score</title>
          <description>NEI-VFQ-25 questionnaire included 25 items based on near activities, which are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning.</description>
          <population>ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="283"/>
                    <count group_id="B2" value="299"/>
                    <count group_id="B3" value="296"/>
                    <count group_id="B4" value="878"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.89" spread="19.91"/>
                    <measurement group_id="B2" value="51.68" spread="21.92"/>
                    <measurement group_id="B3" value="53.24" spread="22.07"/>
                    <measurement group_id="B4" value="52.92" spread="21.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NEI VFQ-25 Distance Activity Subscale Score</title>
          <description>NEI-VFQ-25 questionnaire included 25 items based on which distance activities was measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning.</description>
          <population>ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="283"/>
                    <count group_id="B2" value="299"/>
                    <count group_id="B3" value="296"/>
                    <count group_id="B4" value="878"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.68" spread="21.41"/>
                    <measurement group_id="B2" value="58.57" spread="22.03"/>
                    <measurement group_id="B3" value="60.95" spread="21.55"/>
                    <measurement group_id="B4" value="60.70" spread="21.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean Functional Reading Independence (FRI) Index</title>
          <description>The FRI was an interviewer-administered questionnaire with 7-items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence.</description>
          <population>ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="278"/>
                    <count group_id="B2" value="296"/>
                    <count group_id="B3" value="293"/>
                    <count group_id="B4" value="867"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.70" spread="0.79"/>
                    <measurement group_id="B2" value="2.66" spread="0.82"/>
                    <measurement group_id="B3" value="2.64" spread="0.87"/>
                    <measurement group_id="B4" value="2.67" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>GA Area in Complement Factor I (CFI) Positive Participants</title>
          <description>For CFI profile, positive biomarker status refers to the presence (carrier) of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).</description>
          <population>ITT population included all the participants who were randomized to the study. Reported here is the number of CFI-positive participants for whom data were collected.</population>
          <units>mm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="194"/>
                    <count group_id="B2" value="199"/>
                    <count group_id="B3" value="194"/>
                    <count group_id="B4" value="587"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.491" spread="4.068"/>
                    <measurement group_id="B2" value="8.183" spread="3.835"/>
                    <measurement group_id="B3" value="8.652" spread="4.250"/>
                    <measurement group_id="B4" value="8.109" spread="4.074"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>GA Area in CFI Negative Participants</title>
          <description>For CFI profile, negative biomarker status refers to the absence of the risk allele at CFI and at least one risk allele at CFH or C2/CFB.</description>
          <population>ITT population included all the participants who were randomized to the study. Reported here is the number of CFI-negative participants for whom data were collected.</population>
          <units>mm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="127"/>
                    <count group_id="B2" value="131"/>
                    <count group_id="B3" value="130"/>
                    <count group_id="B4" value="388"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.650" spread="3.862"/>
                    <measurement group_id="B2" value="8.499" spread="4.044"/>
                    <measurement group_id="B3" value="8.268" spread="4.281"/>
                    <measurement group_id="B4" value="8.144" spread="4.073"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48</title>
        <description>The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>Intent-to-treat (ITT) population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in Mixed-effect model repeated measures (MMRM analysis).</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48</title>
          <description>The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).</description>
          <population>Intent-to-treat (ITT) population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in Mixed-effect model repeated measures (MMRM analysis).</population>
          <units>millimeter square (mm^2)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="291"/>
                <count group_id="O2" value="293"/>
                <count group_id="O3" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.932" spread="0.056"/>
                    <measurement group_id="O2" value="2.089" spread="0.056"/>
                    <measurement group_id="O3" value="2.019" spread="0.056"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0479</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.157</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.001</ci_lower_limit>
            <ci_upper_limit>0.313</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2739</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.087</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.069</ci_lower_limit>
            <ci_upper_limit>0.243</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48</title>
        <description>Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48</title>
          <description>Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
          <population>The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
          <units>number of absolute scotomatous points</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="1.6"/>
                    <measurement group_id="O2" value="5.0" spread="1.5"/>
                    <measurement group_id="O3" value="6.7" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8400</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.8</ci_lower_limit>
            <ci_upper_limit>3.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5587</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.1</ci_lower_limit>
            <ci_upper_limit>5.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48</title>
        <description>Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48</title>
          <description>Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
          <population>The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
          <units>decibel (dB)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.99" spread="0.36"/>
                    <measurement group_id="O2" value="-0.89" spread="0.34"/>
                    <measurement group_id="O3" value="-1.25" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8358</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.88</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6117</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-0.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.25</ci_lower_limit>
            <ci_upper_limit>0.74</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48</title>
        <description>BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening.</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48</title>
          <description>BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening.</description>
          <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
          <units>letters</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="288"/>
                <count group_id="O2" value="286"/>
                <count group_id="O3" value="287"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="0.7"/>
                    <measurement group_id="O2" value="-4.6" spread="0.7"/>
                    <measurement group_id="O3" value="-5.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4651</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>2.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7885</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>2.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48</title>
        <description>Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
        <time_frame>Week 48</time_frame>
        <population>ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48</title>
          <description>Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
          <population>ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="288"/>
                <count group_id="O2" value="286"/>
                <count group_id="O3" value="287"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.1"/>
                    <measurement group_id="O2" value="88.2"/>
                    <measurement group_id="O3" value="86.8"/>
                  </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>0.6892</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7</ci_lower_limit>
            <ci_upper_limit>1.8</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>0.9104</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.6</ci_lower_limit>
            <ci_upper_limit>1.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48</title>
        <description>The low luminance visual acuity was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. A negative change from baseline indicates a decrease in the visual acuity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48</title>
          <description>The low luminance visual acuity was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. A negative change from baseline indicates a decrease in the visual acuity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
          <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
          <units>letters</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="278"/>
                <count group_id="O3" value="274"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" spread="0.6"/>
                    <measurement group_id="O2" value="-2.6" spread="0.6"/>
                    <measurement group_id="O3" value="-3.6" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8931</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.8</ci_lower_limit>
            <ci_upper_limit>1.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1754</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.8</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48</title>
        <description>Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
        <time_frame>Week 48</time_frame>
        <population>ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48</title>
          <description>Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
          <population>ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="278"/>
                <count group_id="O3" value="274"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.1" lower_limit="83.7" upper_limit="91.5"/>
                    <measurement group_id="O2" value="92.1" lower_limit="86.4" upper_limit="93.5"/>
                    <measurement group_id="O3" value="89.6" lower_limit="82.9" upper_limit="90.9"/>
                  </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>0.3707</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7</ci_lower_limit>
            <ci_upper_limit>2.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8382</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.6</ci_lower_limit>
            <ci_upper_limit>1.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48</title>
        <description>MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48</title>
          <description>MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
          <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
          <units>words per minute (wpm)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="261"/>
                <count group_id="O2" value="255"/>
                <count group_id="O3" value="266"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.27" spread="2.33"/>
                    <measurement group_id="O2" value="-13.92" spread="2.36"/>
                    <measurement group_id="O3" value="-14.20" spread="2.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6841</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>1.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.16</ci_lower_limit>
            <ci_upper_limit>7.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7443</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.37</ci_lower_limit>
            <ci_upper_limit>7.52</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48</title>
        <description>MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48</title>
          <description>MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
          <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
          <units>wpm</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="264"/>
                <count group_id="O2" value="264"/>
                <count group_id="O3" value="272"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.58" spread="2.30"/>
                    <measurement group_id="O2" value="-16.46" spread="2.30"/>
                    <measurement group_id="O3" value="-18.30" spread="2.27"/>
                  </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>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9713</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.28</ci_lower_limit>
            <ci_upper_limit>6.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5945</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-1.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.08</ci_lower_limit>
            <ci_upper_limit>4.63</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48</title>
        <description>NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health, general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale or total score is the average of items contributing to the score. For each subscale and total score the score range is 0 to 100 with a higher score representing better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48</title>
          <description>NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health, general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale or total score is the average of items contributing to the score. For each subscale and total score the score range is 0 to 100 with a higher score representing better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
          <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="251"/>
                <count group_id="O2" value="259"/>
                <count group_id="O3" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.08" spread="0.74"/>
                    <measurement group_id="O2" value="-0.86" spread="0.73"/>
                    <measurement group_id="O3" value="-1.05" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2438</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>1.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.83</ci_lower_limit>
            <ci_upper_limit>3.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3202</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.01</ci_lower_limit>
            <ci_upper_limit>3.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48</title>
        <description>NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48</title>
          <description>NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
          <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="251"/>
                <count group_id="O2" value="259"/>
                <count group_id="O3" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.12" spread="0.91"/>
                    <measurement group_id="O2" value="-1.49" spread="0.89"/>
                    <measurement group_id="O3" value="-1.93" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0388</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>2.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.14</ci_lower_limit>
            <ci_upper_limit>5.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0833</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>2.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.29</ci_lower_limit>
            <ci_upper_limit>4.68</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48</title>
        <description>NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48</title>
          <description>NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
          <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="251"/>
                <count group_id="O2" value="259"/>
                <count group_id="O3" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.83" spread="1.04"/>
                    <measurement group_id="O2" value="-1.80" spread="1.03"/>
                    <measurement group_id="O3" value="-2.24" spread="1.01"/>
                  </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>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4795</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.84</ci_lower_limit>
            <ci_upper_limit>3.91</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6822</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.26</ci_lower_limit>
            <ci_upper_limit>3.45</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48</title>
        <description>The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48</title>
          <description>The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.</description>
          <population>ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="248"/>
                <count group_id="O2" value="257"/>
                <count group_id="O3" value="260"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.16" spread="0.04"/>
                    <measurement group_id="O2" value="-0.12" spread="0.04"/>
                    <measurement group_id="O3" value="-0.14" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5227</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.07</ci_lower_limit>
            <ci_upper_limit>0.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7475</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>0.13</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48</title>
        <description>For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).</description>
        <time_frame>Baseline, Week 48</time_frame>
        <population>ITT population included all the participants who were randomized to the study. The analysis was done specifically for CFI-positive and negative participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48</title>
          <description>For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).</description>
          <population>ITT population included all the participants who were randomized to the study. The analysis was done specifically for CFI-positive and negative participants.</population>
          <units>mm^2</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="321"/>
                <count group_id="O2" value="330"/>
                <count group_id="O3" value="324"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CFI-Positive Participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="183"/>
                    <count group_id="O3" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.007" spread="0.074"/>
                    <measurement group_id="O2" value="2.057" spread="0.072"/>
                    <measurement group_id="O3" value="2.032" spread="0.073"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFI-Negative Participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="115"/>
                    <count group_id="O2" value="110"/>
                    <count group_id="O3" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.809" spread="0.087"/>
                    <measurement group_id="O2" value="2.149" spread="0.087"/>
                    <measurement group_id="O3" value="1.991" spread="0.085"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6333</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.049</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.153</ci_lower_limit>
            <ci_upper_limit>0.252</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8105</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.025</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.180</ci_lower_limit>
            <ci_upper_limit>0.230</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0063</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.340</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.097</ci_lower_limit>
            <ci_upper_limit>0.584</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1359</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.182</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.058</ci_lower_limit>
            <ci_upper_limit>0.422</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to approximately 2 years</time_frame>
      <desc>Safety population included all participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Sham Comparator</title>
          <description>Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit.</description>
        </group>
        <group group_id="E2">
          <title>Lampalizumab Q4W</title>
          <description>Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit.</description>
        </group>
        <group group_id="E3">
          <title>Lampalizumab Q6W</title>
          <description>Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA, version 20.1</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="9" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="99" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="113" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="111" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Aortic valve stenosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Atrioventricular dissociation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Left ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Mitral valve prolapse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous malformation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness unilateral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blindness transient</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Choroidal neovascularisation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Dry age-related macular degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Neovascular age-related macular degeneration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Open angle glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Optic ischaemic neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Ulcerative keratitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Uveitic glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Vitreous floaters</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Vitreous haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Posterior capsule opacification</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced transiently</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Gastrointestinal ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Incarcerated inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Obstructive pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Volvulus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Complication associated with device</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Stent-graft endoleak</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Endometritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Endophthalmitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Enterococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Ophthalmic herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Periorbital cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pneumonia mycoplasmal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </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" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Acetabulum fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Comminuted fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Fracture displacement</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Incarcerated incisional hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Incomplete spinal fusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Patella fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pubis fracture</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Sternal fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Traumatic intracranial haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Brain herniation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Corneal abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>International normalised ratio abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>B-cell lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Bone cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Breast cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cervix carcinoma stage IV</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Colon neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Hepatic cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Laryngeal cancer stage I</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Lip squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Lung cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm of unknown primary site</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Oesophageal cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Renal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Salivary gland neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Small intestine carcinoma metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of the vulva</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Vulval cancer stage 0</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Waldenstrom's macroglobulinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Carotid artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Hepatic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>IIIrd nerve paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Mental disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Bladder cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Lower urinary tract symptoms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </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" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Endometrial hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Chronic respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Sinus polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin necrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Fracture treatment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Peripheral artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA, version 20.1</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="227" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="268" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="253" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="84" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="112" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="97" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="36" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Vitreous detachment</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="31" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Retinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Vitreous floaters</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Posterior capsule opacification</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="36" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="32" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="39" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="323"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="318"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="323"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but only after the first publication or presentation that involves the overall study. The Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study was terminated early by the Sponsor because the compound had demonstrated lack of efficacy. Thus, not all participants in this study completed the full duration of treatment.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800 821-8590</phone>
      <email>genentech@druginfo.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02247531
org study id: GX29185
secondary id: 2014-000106-35
nct id: NCT02247531
lead sponsor: 
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled
      study evaluating the efficacy and safety of lampalizumab administered by intravitreal
      injections in participants with geographic atrophy (GA) secondary to age-related macular
      degeneration (AMD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48
time frame: Baseline, Week 48
description: The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
measure: Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48
time frame: Baseline, Week 48
description: For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
measure: Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48
time frame: Baseline, Week 48
description: Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
measure: Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48
time frame: Baseline, Week 48
description: Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48
time frame: Baseline, Week 48
description: BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening.
measure: Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48
time frame: Week 48
description: Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
measure: Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48
time frame: Baseline, Week 48
description: The low luminance visual acuity was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. A negative change from baseline indicates a decrease in the visual acuity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
measure: Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48
time frame: Week 48
description: Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
measure: Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48
time frame: Baseline, Week 48
description: MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
measure: Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48
time frame: Baseline, Week 48
description: MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
measure: Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48
time frame: Baseline, Week 48
description: NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health, general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale or total score is the average of items contributing to the score. For each subscale and total score the score range is 0 to 100 with a higher score representing better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
measure: Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48
time frame: Baseline, Week 48
description: NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
measure: Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48
time frame: Baseline, Week 48
description: NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
measure: Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48
time frame: Baseline, Week 48
description: The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
arm group label: Lampalizumab once in every 4 weeks (Q4W)
arm group type: Experimental
description: Participants will receive 10 mg (milligrams) dose of lampalizumab by intravitreal injection, Q4W, starting at the Day 1 visit for approximately 92 weeks.
arm group label: Lampalizumab once in every 6 weeks (Q6W)
arm group type: Experimental
description: Participants will receive 10 mg dose of lampalizumab by intravitreal injection, Q6W, starting at the Day 1 visit for approximately 90 weeks.
arm group label: Sham Comparator
arm group type: Sham Comparator
description: Participants will receive sham comparator, Q4W, starting at the Day 1 visit for approximately 92 weeks or Q6W, starting at the Day 1 visit for approximately 90 weeks.
intervention type: Drug
intervention name: Lampalizumab
description: 10 mg dose of lampalizumab administered intravitreally.
arm group label: Lampalizumab once in every 4 weeks (Q4W)
arm group label: Lampalizumab once in every 6 weeks (Q6W)
other name: RO5490249
intervention type: Other
intervention name: Sham Comparator
description: A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.
arm group label: Sham Comparator
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Argentina
country: Australia
country: Austria
country: Belgium
country: Denmark
country: France
country: Germany
country: Hungary
country: Italy
country: Mexico
country: Netherlands
country: Peru
country: Poland
country: Portugal
country: Russian Federation
country: Slovakia
country: Spain
country: Sweden
country: Switzerland
country: Turkey
country: United Kingdom
country: United States
country: Brazil
country: Canada
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Geographic Atrophy
mesh term: Atrophy
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reported events: 
certain agreements: 
limitations and caveats: This study was terminated early by the Sponsor because the compound had demonstrated lack of efficacy. Thus, not all participants in this study completed the full duration of treatment.
point of contact: 