<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/NCT02247479</url>
  </required_header>
  <id_info>
    <org_study_id>GX29176</org_study_id>
    <secondary_id>2014-000107-27</secondary_id>
    <nct_id>NCT02247479</nct_id>
  </id_info>
  <brief_title>A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration</brief_title>
  <acronym>CHROMA</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>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <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">September 18, 2014</start_date>
  <completion_date type="Actual">January 29, 2018</completion_date>
  <primary_completion_date type="Actual">January 29, 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 Atrophy (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 as Assessed by Mesopic Micrometry 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, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean 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. 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 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). 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). A negative change from baseline indicates a decrease in the visual acuity; 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>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). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). 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 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 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. LLVA 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). 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>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. 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 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. 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 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 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 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, 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. A negative change from baseline indicates a decrease in the visual functioning; 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 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">906</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 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 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 administered by intravitreal injections for approximately 96 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 or Q6W for 96 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lampalizumab</intervention_name>
    <description>Participants will receive 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</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;
          -  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 (intravitreal corticosteroid injection,&#xD;
             anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular&#xD;
             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>Uni of Alabama At Birmingham Clinical Research Unit</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retinal Research Institute, LLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Centers P.C.</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Retina Consultants</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina-Vitreous Associates Medical Group</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Gavin Herbert Eye Institute - UC, Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697-4375</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>East Bay Retina Consultants</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern CA Desert Retina Cons</name>
      <address>
        <city>Palm Desert</city>
        <state>California</state>
        <zip>92211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>W Coast Retina Med Group Inc</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF; Ophthalmology</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orange County Retina Med Group</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</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>Florida Eye Microsurgical Inst</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Ophthalmic Research Institute</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Eye Associates</name>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Care Specialists</name>
      <address>
        <city>Palm Beach Gardens</city>
        <state>Florida</state>
        <zip>33410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bascom Palmer Eye Institute</name>
      <address>
        <city>Palm Beach Gardens</city>
        <state>Florida</state>
        <zip>33418</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Specialty Institute</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fort Lauderdale Eye Institute</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33324</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>Retina Associates of Florida, LLC</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Retina Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Retina PC</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Hawaii</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Medical Group/Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Retina and Macula Associates, PC</name>
      <address>
        <city>Oak Forest</city>
        <state>Illinois</state>
        <zip>60452</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Eye Institute Northside</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</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>Retina Associates</name>
      <address>
        <city>Shawnee Mission</city>
        <state>Kansas</state>
        <zip>66204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lahey Clinic Med Ctr</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>02421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Associates of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Eye Center</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04101</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>Tufts Medical Center Research</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmic Consultants of Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitreo-Retinal Associates, PC</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitreo-Retinal Associates</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialty Eye Institute</name>
      <address>
        <city>Jackson</city>
        <state>Michigan</state>
        <zip>49202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assoc Retinal Consultants PC</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Michigan</name>
      <address>
        <city>Southfield</city>
        <state>Michigan</state>
        <zip>48034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Surgical Associates</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Center of New Jersey</name>
      <address>
        <city>Bloomfield</city>
        <state>New Jersey</state>
        <zip>07003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Jersey Retina Research Foundation</name>
      <address>
        <city>Edison</city>
        <state>New Jersey</state>
        <zip>08820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delaware Valley Retina Assoc</name>
      <address>
        <city>Lawrenceville</city>
        <state>New Jersey</state>
        <zip>08648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Is. Vitreoretinal Consult</name>
      <address>
        <city>Hauppauge</city>
        <state>New York</state>
        <zip>11788</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Opthalmic Consultants of LI</name>
      <address>
        <city>Lynbrook</city>
        <state>New York</state>
        <zip>11563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Eye &amp; Ear Infirmary</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Western New York</name>
      <address>
        <city>Orchard Park</city>
        <state>New York</state>
        <zip>14127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Vit Surgeons/Central NY</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13224</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>Wake Forest Baptist Health Eye Centre</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Assoc of Cleveland Inc</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation; Cole Eye Institute</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Vitreous Consultants</name>
      <address>
        <city>Monroeville</city>
        <state>Pennsylvania</state>
        <zip>15146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associates in Ophthalmology</name>
      <address>
        <city>West Mifflin</city>
        <state>Pennsylvania</state>
        <zip>15122</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>Tennessee Retina PC.</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</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>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Retina Associates</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Research Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern MC at Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Retina Institute P.A.</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strategic Clinical Research Group, LLC</name>
      <address>
        <city>Willow Park</city>
        <state>Texas</state>
        <zip>76087</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Associates of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Surgeons of Richmond Inc. dba Virginia Eye Institute</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Institute of Virginia</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Retina Center</name>
      <address>
        <city>Warrenton</city>
        <state>Virginia</state>
        <zip>20186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Center Northwest</name>
      <address>
        <city>Silverdale</city>
        <state>Washington</state>
        <zip>98383</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spokane Eye Clinical Research</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Eye Institute</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Organizacion Medica de Investigacion</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1015ABO</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Zambrano</name>
      <address>
        <city>Caba</city>
        <zip>1023</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oftar</name>
      <address>
        <city>Mendoza</city>
        <zip>M5500GGK</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Microcirugía Ocular S.A</name>
      <address>
        <city>Rosario</city>
        <zip>S2000CTC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grupo Laser Vision</name>
      <address>
        <city>Rosario</city>
        <zip>S2000DLA</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eyeclinic Albury Wodonga</name>
      <address>
        <city>Albury</city>
        <state>New South Wales</state>
        <zip>2640</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marsden Eye Research Centre</name>
      <address>
        <city>Parramatta</city>
        <state>New South Wales</state>
        <zip>2150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Save Sight Institute</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sydney West Retina</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde</name>
      <address>
        <city>Linz</city>
        <zip>4021</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 Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</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>CHU Sart-Tilman</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calgary Retina Consultants</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2J 0C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QEII - HSC Department of Ophthalmology</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Ottawa Eye Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Michael'S Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut De L'Oeil Des Laurentides</name>
      <address>
        <city>Boisbriand</city>
        <state>Quebec</state>
        <zip>J7H 1S6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sjællands Universitetshospital, Roskilde; Øjenafdelingen</name>
      <address>
        <city>Roskilde</city>
        <zip>4000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chi De Creteil; Ophtalmologie</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Odeon; Exploration Ophtalmologique</name>
      <address>
        <city>Paris</city>
        <zip>75006</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Lariboisiere; Ophtalmologie</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Ophtalmologique; Imagerie et laser</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Pitie Salpetriere; Ophtalmologie</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Poitiers - CHR La Miletrie; Ophtalmologie</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäts-Augenklinik Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde</name>
      <address>
        <city>Göttingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover, Klinik für Augenheilkunde</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Köln; Augenklinik</name>
      <address>
        <city>Köln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde</name>
      <address>
        <city>Lübeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augenabteilung am St. Franziskus-Hospital</name>
      <address>
        <city>Münster</city>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster; Augenheilkunde</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Budapest Retina Associates Kft.</name>
      <address>
        <city>Budapest</city>
        <zip>1133</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika</name>
      <address>
        <city>Debrecem</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ganglion Medial Center</name>
      <address>
        <city>Pecs</city>
        <zip>7621</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00198</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica</name>
      <address>
        <city>Sassari</city>
        <state>Sardegna</state>
        <zip>07100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macula Retina Consultores</name>
      <address>
        <city>Mexico, D.F.</city>
        <zip>01120</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Ceguera APEC</name>
      <address>
        <city>Mexico, D.F.</city>
        <zip>04030</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academisch Medisch Centrum Universiteit Amsterdam</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leids Universitair Medisch Centrum</name>
      <address>
        <city>Leiden</city>
        <zip>2333 ZA0</zip>
        <country>Netherlands</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>CLINICA RICARDO PALMA; Oftalmologos Contreras</name>
      <address>
        <city>Lima</city>
        <zip>27</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Anglo Americana</name>
      <address>
        <city>Lima</city>
        <zip>Lima 27</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>Optimum Profesorskie Centrum Okulistyki</name>
      <address>
        <city>Gdańsk</city>
        <zip>80-809</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabinet Okulistyczny Prof Edward Wylegala</name>
      <address>
        <city>Katowice</city>
        <zip>40-594</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej</name>
      <address>
        <city>Krakow</city>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnica sv. Michala, a.s.</name>
      <address>
        <city>Bratislava</city>
        <zip>81108</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultna nemocnica Trencin Ocna klinika</name>
      <address>
        <city>Trencin</city>
        <zip>911 71</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie</name>
      <address>
        <city>Zilina</city>
        <zip>012 07</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge; Servicio de Oftalmologia</name>
      <address>
        <city>Hospitalet De Llobregat</city>
        <state>Barcelona</state>
        <zip>8907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Catalunya</name>
      <address>
        <city>San Cugat Del Valles</city>
        <state>Barcelona</state>
        <zip>08195</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Clinico Quirurgico de Oftalmologia - ICQO</name>
      <address>
        <city>Bilbao</city>
        <state>Guipuzcoa</state>
        <zip>48006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VISSUM Instituto Oftalmológico de Alicante</name>
      <address>
        <city>Alicante</city>
        <zip>03016</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de la Macula i la retina</name>
      <address>
        <city>Barcelona</city>
        <zip>08022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FISABIO. Fundación Oftalmologica del Mediterraneo</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Rio Hortega; Servicio de Oftalmologia</name>
      <address>
        <city>Valladolid</city>
        <zip>47012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stadtspital Triemli; Augenklinik</name>
      <address>
        <city>Zürich</city>
        <zip>8063</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ayr Hospital</name>
      <address>
        <city>AYR</city>
        <zip>KA6 6DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Princess Alexandra Eye Pavilion</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH3 9HA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frimley Park Hospital</name>
      <address>
        <city>Frimley</city>
        <zip>GU16 7UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hallamshire Hospita</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</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>Slovakia</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
  </removed_countries>
  <verification_date>June 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 22, 2019</results_first_submitted>
  <results_first_submitted_qc>April 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 23, 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>June 17, 2019</last_update_submitted>
  <last_update_submitted_qc>June 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 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>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT02247479/SAP_000.pdf</document_url>
    </provided_document>
    <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/79/NCT02247479/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 906 participants were randomized to the study from 131 investigation sites across 19 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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
        </group>
        <group group_id="P2">
          <title>Lampalizumab Q4W</title>
          <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
        </group>
        <group group_id="P3">
          <title>Lampalizumab Q6W</title>
          <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at 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="305"/>
                <participants group_id="P2" count="298"/>
                <participants group_id="P3" count="303"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="163"/>
                <participants group_id="P2" count="160"/>
                <participants group_id="P3" count="165"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="142"/>
                <participants group_id="P2" count="138"/>
                <participants group_id="P3" count="138"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="24"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
                <participants group_id="P2" count="88"/>
                <participants group_id="P3" count="94"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unspecified Reason</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) population included all the participants who were randomized to the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Sham Comparator</title>
          <description>Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
        </group>
        <group group_id="B2">
          <title>Lampalizumab Q4W</title>
          <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
        </group>
        <group group_id="B3">
          <title>Lampalizumab Q6W</title>
          <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at 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="305"/>
            <count group_id="B2" value="298"/>
            <count group_id="B3" value="303"/>
            <count group_id="B4" value="906"/>
          </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="305"/>
                    <count group_id="B2" value="298"/>
                    <count group_id="B3" value="303"/>
                    <count group_id="B4" value="906"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78.5" spread="7.8"/>
                    <measurement group_id="B2" value="77.5" spread="7.9"/>
                    <measurement group_id="B3" value="78.3" spread="8.5"/>
                    <measurement group_id="B4" value="78.1" 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="305"/>
                    <count group_id="B2" value="298"/>
                    <count group_id="B3" value="303"/>
                    <count group_id="B4" value="906"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="186"/>
                    <measurement group_id="B2" value="182"/>
                    <measurement group_id="B3" value="185"/>
                    <measurement group_id="B4" value="553"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                    <measurement group_id="B2" value="116"/>
                    <measurement group_id="B3" value="118"/>
                    <measurement group_id="B4" value="353"/>
                  </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="305"/>
                    <count group_id="B2" value="298"/>
                    <count group_id="B3" value="303"/>
                    <count group_id="B4" value="906"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <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="302"/>
                    <measurement group_id="B2" value="294"/>
                    <measurement group_id="B3" value="295"/>
                    <measurement group_id="B4" value="891"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiple</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="11"/>
                  </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="305"/>
                    <count group_id="B2" value="298"/>
                    <count group_id="B3" value="303"/>
                    <count group_id="B4" value="906"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="279"/>
                    <measurement group_id="B2" value="278"/>
                    <measurement group_id="B3" value="282"/>
                    <measurement group_id="B4" value="839"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Stated</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>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </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>
          <population>ITT population included all the participants who were randomized to the study. Reported here are the number of participants for whom data was collected.</population>
          <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="305"/>
                    <count group_id="B2" value="298"/>
                    <count group_id="B3" value="302"/>
                    <count group_id="B4" value="905"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.953" spread="3.925"/>
                    <measurement group_id="B2" value="7.910" spread="3.887"/>
                    <measurement group_id="B3" value="8.116" spread="4.236"/>
                    <measurement group_id="B4" value="7.993" spread="4.016"/>
                  </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, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. 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>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="44"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="39"/>
                    <count group_id="B4" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.1" spread="16.8"/>
                    <measurement group_id="B2" value="25.2" spread="13.4"/>
                    <measurement group_id="B3" value="20.5" spread="13.4"/>
                    <measurement group_id="B4" value="25.1" spread="15.1"/>
                  </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="44"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="39"/>
                    <count group_id="B4" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.40" spread="3.37"/>
                    <measurement group_id="B2" value="6.37" spread="4.02"/>
                    <measurement group_id="B3" value="7.38" spread="3.40"/>
                    <measurement group_id="B4" value="6.34" spread="3.64"/>
                  </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. 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 are the number of participants for whom data was 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="301"/>
                    <count group_id="B2" value="295"/>
                    <count group_id="B3" value="301"/>
                    <count group_id="B4" value="897"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.9" spread="9.9"/>
                    <measurement group_id="B2" value="66.1" spread="10.0"/>
                    <measurement group_id="B3" value="66.4" spread="10.1"/>
                    <measurement group_id="B4" value="66.2" spread="10.0"/>
                  </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. LLVA 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 are the number of participants for whom data was 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="299"/>
                    <count group_id="B2" value="287"/>
                    <count group_id="B3" value="293"/>
                    <count group_id="B4" value="879"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.0" spread="15.7"/>
                    <measurement group_id="B2" value="36.9" spread="17.8"/>
                    <measurement group_id="B3" value="36.2" spread="16.7"/>
                    <measurement group_id="B4" value="36.4" spread="16.7"/>
                  </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 are the number of participants for whom data was 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="278"/>
                    <count group_id="B2" value="262"/>
                    <count group_id="B3" value="269"/>
                    <count group_id="B4" value="809"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="106.89" spread="57.98"/>
                    <measurement group_id="B2" value="109.18" spread="60.14"/>
                    <measurement group_id="B3" value="104.22" spread="62.37"/>
                    <measurement group_id="B4" value="106.74" spread="60.12"/>
                  </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 are the number of participants for whom data was 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="276"/>
                    <count group_id="B2" value="275"/>
                    <count group_id="B3" value="282"/>
                    <count group_id="B4" value="833"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.16" spread="17.33"/>
                    <measurement group_id="B2" value="64.80" spread="16.12"/>
                    <measurement group_id="B3" value="65.19" spread="17.27"/>
                    <measurement group_id="B4" value="65.38" spread="16.91"/>
                  </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 are the number of participants for whom data was 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="276"/>
                    <count group_id="B2" value="273"/>
                    <count group_id="B3" value="280"/>
                    <count group_id="B4" value="829"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.69" spread="0.83"/>
                    <measurement group_id="B2" value="2.71" spread="0.79"/>
                    <measurement group_id="B3" value="2.70" spread="0.82"/>
                    <measurement group_id="B4" value="2.70" spread="0.81"/>
                  </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 are the number of participants for whom data was 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="276"/>
                    <count group_id="B2" value="275"/>
                    <count group_id="B3" value="282"/>
                    <count group_id="B4" value="833"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.98" spread="20.98"/>
                    <measurement group_id="B2" value="53.78" spread="20.56"/>
                    <measurement group_id="B3" value="53.67" spread="22.21"/>
                    <measurement group_id="B4" value="54.14" spread="21.25"/>
                  </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 are the number of participants for whom data was 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="276"/>
                    <count group_id="B2" value="275"/>
                    <count group_id="B3" value="282"/>
                    <count group_id="B4" value="833"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.86" spread="21.46"/>
                    <measurement group_id="B2" value="60.97" spread="20.48"/>
                    <measurement group_id="B3" value="62.10" spread="22.16"/>
                    <measurement group_id="B4" value="61.98" spread="21.37"/>
                  </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 the 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 are the number of participants for whom data was 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="278"/>
                    <count group_id="B2" value="265"/>
                    <count group_id="B3" value="271"/>
                    <count group_id="B4" value="814"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80.89" spread="52.95"/>
                    <measurement group_id="B2" value="85.18" spread="54.55"/>
                    <measurement group_id="B3" value="79.49" spread="54.23"/>
                    <measurement group_id="B4" value="81.82" spread="53.89"/>
                  </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 are the number of participants for whom data was 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="181"/>
                    <count group_id="B2" value="176"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="534"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.015" spread="3.915"/>
                    <measurement group_id="B2" value="8.152" spread="4.118"/>
                    <measurement group_id="B3" value="8.406" spread="4.399"/>
                    <measurement group_id="B4" value="8.190" spread="4.142"/>
                  </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 are the number of participants for whom data was 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="124"/>
                    <count group_id="B2" value="122"/>
                    <count group_id="B3" value="125"/>
                    <count group_id="B4" value="371"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.864" spread="3.952"/>
                    <measurement group_id="B2" value="7.560" spread="3.515"/>
                    <measurement group_id="B3" value="7.705" spread="3.975"/>
                    <measurement group_id="B4" value="7.710" spread="3.814"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Geographic Atrophy (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>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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Geographic Atrophy (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>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="274"/>
                <count group_id="O2" value="259"/>
                <count group_id="O3" value="270"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.035" spread="0.066"/>
                    <measurement group_id="O2" value="2.016" spread="0.068"/>
                    <measurement group_id="O3" value="2.086" spread="0.067"/>
                  </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>0.8381</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-0.019</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.206</ci_lower_limit>
            <ci_upper_limit>0.167</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>0.5901</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.051</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.134</ci_lower_limit>
            <ci_upper_limit>0.236</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry 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, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening.</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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry 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, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening.</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>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="30"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" spread="1.7"/>
                    <measurement group_id="O2" value="8.1" spread="1.8"/>
                    <measurement group_id="O3" value="8.3" spread="1.8"/>
                  </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>
            <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>0.9350</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.2</ci_lower_limit>
            <ci_upper_limit>4.8</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>0.9789</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>-5.0</ci_lower_limit>
            <ci_upper_limit>5.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean 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. 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>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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at Day 1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean 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. The data was 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="30"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.61" spread="0.33"/>
                    <measurement group_id="O2" value="-1.33" spread="0.34"/>
                    <measurement group_id="O3" value="-2.24" 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>0.5538</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.66</ci_lower_limit>
            <ci_upper_limit>1.22</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>0.2032</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-0.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.60</ci_lower_limit>
            <ci_upper_limit>0.35</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). 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). A negative change from baseline indicates a decrease in the visual acuity; 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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at 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). 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). A negative change from baseline indicates a decrease in the visual acuity; 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>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="267"/>
                <count group_id="O2" value="259"/>
                <count group_id="O3" value="261"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5" spread="0.6"/>
                    <measurement group_id="O2" value="-3.4" spread="0.6"/>
                    <measurement group_id="O3" value="-4.6" 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 BCVA, GA lesion location, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2547</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>2.8</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>0.8423</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>1.6</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). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was 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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at 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). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). 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. Reported here is the number of participants for whom data were collected.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="267"/>
                <count group_id="O2" value="259"/>
                <count group_id="O3" value="262"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.8" lower_limit="81.6" upper_limit="90.0"/>
                    <measurement group_id="O2" value="88.8" lower_limit="85.0" upper_limit="92.6"/>
                    <measurement group_id="O3" value="87.0" lower_limit="83.0" upper_limit="91.1"/>
                  </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: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3248</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>0.8</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>
            <groups_desc>Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7209</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_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 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. LLVA 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). 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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at 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 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. LLVA 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). 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>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="265"/>
                <count group_id="O2" value="251"/>
                <count group_id="O3" value="252"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="0.7"/>
                    <measurement group_id="O2" value="-2.4" spread="0.7"/>
                    <measurement group_id="O3" value="-2.7" 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 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>0.5695</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.4</ci_lower_limit>
            <ci_upper_limit>2.6</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>0.7865</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>-1.7</ci_lower_limit>
            <ci_upper_limit>2.3</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. The data was 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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at 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. 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. Reported here is the number of participants for whom data were collected.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="265"/>
                <count group_id="O2" value="251"/>
                <count group_id="O3" value="253"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.8" lower_limit="82.7" upper_limit="90.9"/>
                    <measurement group_id="O2" value="85.3" lower_limit="80.9" upper_limit="89.6"/>
                    <measurement group_id="O3" value="86.6" lower_limit="82.4" upper_limit="90.8"/>
                  </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>
            <groups_desc>Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline 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>0.9448</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>1.7</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: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline 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>0.8764</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>1.8</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. 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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at 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. 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>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="242"/>
                <count group_id="O2" value="223"/>
                <count group_id="O3" value="229"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.97" spread="2.37"/>
                    <measurement group_id="O2" value="-13.32" spread="2.47"/>
                    <measurement group_id="O3" value="-19.96" spread="2.44"/>
                  </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>0.0991</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>5.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.07</ci_lower_limit>
            <ci_upper_limit>12.38</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>0.7713</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.66</ci_lower_limit>
            <ci_upper_limit>5.69</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 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 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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at 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 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 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="243"/>
                <count group_id="O2" value="229"/>
                <count group_id="O3" value="233"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.63" spread="2.41"/>
                    <measurement group_id="O2" value="-17.91" spread="2.49"/>
                    <measurement group_id="O3" value="-18.16" spread="2.47"/>
                  </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>MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6204</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>-5.09</ci_lower_limit>
            <ci_upper_limit>8.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6705</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>1.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.31</ci_lower_limit>
            <ci_upper_limit>8.25</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, 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. A negative change from baseline indicates a decrease in the visual functioning; 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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at 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, 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. A negative change from baseline indicates a decrease in the visual functioning; 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>scores 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="239"/>
                <count group_id="O2" value="234"/>
                <count group_id="O3" value="248"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.31" spread="0.71"/>
                    <measurement group_id="O2" value="-1.66" spread="0.72"/>
                    <measurement group_id="O3" value="-2.87" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.7246</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-0.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.35</ci_lower_limit>
            <ci_upper_limit>1.64</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>0.1193</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-1.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.53</ci_lower_limit>
            <ci_upper_limit>0.40</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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at 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="239"/>
                <count group_id="O2" value="234"/>
                <count group_id="O3" value="248"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.12" spread="0.93"/>
                    <measurement group_id="O2" value="-2.35" spread="0.94"/>
                    <measurement group_id="O3" value="-4.06" spread="0.92"/>
                  </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>0.8659</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-0.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.84</ci_lower_limit>
            <ci_upper_limit>2.39</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>0.1399</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-1.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.51</ci_lower_limit>
            <ci_upper_limit>0.64</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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at 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="239"/>
                <count group_id="O2" value="234"/>
                <count group_id="O3" value="248"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.03" spread="0.99"/>
                    <measurement group_id="O2" value="-1.04" spread="1.00"/>
                    <measurement group_id="O3" value="-3.62" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <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>0.4855</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.79</ci_lower_limit>
            <ci_upper_limit>3.76</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>0.2515</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-1.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.33</ci_lower_limit>
            <ci_upper_limit>1.13</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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at 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="237"/>
                <count group_id="O2" value="230"/>
                <count group_id="O3" value="244"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.04"/>
                    <measurement group_id="O2" value="-0.13" spread="0.04"/>
                    <measurement group_id="O3" value="-0.15" 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>0.2075</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.18</ci_lower_limit>
            <ci_upper_limit>0.04</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>0.1222</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-0.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.19</ci_lower_limit>
            <ci_upper_limit>0.02</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. Number analyzed for each row signifies the participants evaluated for specified categories for each reporting group.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Comparator</title>
            <description>Participants received sham comparator once in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
          </group>
          <group group_id="O2">
            <title>Lampalizumab Q4W</title>
            <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
          </group>
          <group group_id="O3">
            <title>Lampalizumab Q6W</title>
            <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at 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. Number analyzed for each row signifies the participants evaluated for specified categories for each reporting group.</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="305"/>
                <count group_id="O2" value="298"/>
                <count group_id="O3" value="303"/>
              </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="162"/>
                    <count group_id="O2" value="152"/>
                    <count group_id="O3" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.067" spread="0.086"/>
                    <measurement group_id="O2" value="2.045" spread="0.089"/>
                    <measurement group_id="O3" value="2.144" spread="0.087"/>
                  </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="112"/>
                    <count group_id="O2" value="107"/>
                    <count group_id="O3" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.006" spread="0.103"/>
                    <measurement group_id="O2" value="1.974" spread="0.105"/>
                    <measurement group_id="O3" value="2.012" spread="0.104"/>
                  </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>0.8612</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-0.022</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.266</ci_lower_limit>
            <ci_upper_limit>0.223</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>0.5317</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.077</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.165</ci_lower_limit>
            <ci_upper_limit>0.319</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>0.8240</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>-0.033</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.322</ci_lower_limit>
            <ci_upper_limit>0.257</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>0.9676</p_value>
            <method>MMRM</method>
            <param_type>Difference in Adjusted Means</param_type>
            <param_value>0.006</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.283</ci_lower_limit>
            <ci_upper_limit>0.294</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 in every 4 weeks (Q4W) or once in every 6 weeks (Q6W) starting at Day 1 visit.</description>
        </group>
        <group group_id="E2">
          <title>Lampalizumab Q4W</title>
          <description>Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q4W starting at Day 1 visit.</description>
        </group>
        <group group_id="E3">
          <title>Lampalizumab Q6W</title>
          <description>Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q6W starting at 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="6" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="97" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="118" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="108" subjects_at_risk="303"/>
              </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="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </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="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial septal defect</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </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="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Borderline glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Choroidal neovascularisation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Iritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Neovascular age-related macular degeneration</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Open angle glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Retinal artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Retinal neovascularisation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Retinal tear</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced transiently</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Vitreous haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Vitritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Dry age-related macular degeneration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Diverticular hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Gastric volvulus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Gastroduodenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Oesophagitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Rectal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Gastrointestinal angiectasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Obstructive pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Campylobacter infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Perihepatic abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Endophthalmitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </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="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Acetabulum fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Comminuted fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Dislocation of vertebra</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Internal injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Muscle rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Sternal fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Corneal abrasion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Hyphaema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cervical vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Foreign body in eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Traumatic intracranial haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Heart rate irregular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Myocardial necrosis marker increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Prostatic specific antigen increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="303"/>
              </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="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </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="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Haemarthrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Neuropathic arthropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Benign neoplasm of ureter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Bronchial carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cholangiocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Endometrial cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Lung cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Malignant melanoma stage IV</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Malignant pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Myxofibrosarcoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Neoplasm skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Neuroendocrine carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Non-small cell lung cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Oesophageal carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Ovarian cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Ovarian cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Prostate cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Skin cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Bladder neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Urethral cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amyotrophic lateral sclerosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cerebral haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cerebral microangiopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cervicogenic vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Dementia Alzheimer's type</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Dural arteriovenous fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Generalised tonic-clonic seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Senile dementia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Vertigo CNS origin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Bladder cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Oliguria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Urinary bladder polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Postmenopausal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Uterovaginal prolapse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Bronchial hyperreactivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Epiglottic cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Pulmonary air leakage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cardiac pacemaker battery replacement</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Blood pressure inadequately controlled</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>May-Thurner syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Peripheral embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
              </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="221" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="239" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="232" subjects_at_risk="303"/>
              </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="300"/>
                <counts group_id="E2" subjects_affected="111" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="93" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="33" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Vitreous floaters</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Vitreous detachment</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Posterior capsule opacification</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Retinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Punctate keratitis</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="34" subjects_at_risk="303"/>
              </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="36" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="34" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="303"/>
              </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="25" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="303"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="303"/>
              </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="9" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="303"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="298"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="303"/>
              </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 to 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/NCT02247479
org study id: GX29176
secondary id: 2014-000107-27
nct id: NCT02247479
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
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 Atrophy (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 as Assessed by Mesopic Micrometry 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, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening.
measure: Change From Baseline in Mean 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. The data was 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). 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). A negative change from baseline indicates a decrease in the visual acuity; disease worsening. The data was 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 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). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was 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 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. LLVA 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). The data was 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. The data was 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. The data was 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 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 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, 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. A negative change from baseline indicates a decrease in the visual functioning; 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 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 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
arm group label: Lampalizumab Once in Every 6 Weeks (Q6W)
arm group type: Experimental
description: Participants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
arm group label: Sham Comparator
arm group type: Sham Comparator
description: Participants will receive sham comparator Q4W or Q6W for 96 weeks.
intervention type: Drug
intervention name: Lampalizumab
description: Participants will receive 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
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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facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Argentina
country: Australia
country: Austria
country: Belgium
country: Canada
country: Denmark
country: France
country: Germany
country: Hungary
country: Italy
country: Mexico
country: Netherlands
country: Peru
country: Poland
country: Slovakia
country: Spain
country: Switzerland
country: United Kingdom
country: United States
country: Brazil
country: Portugal
country: Russian Federation
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Geographic Atrophy
mesh term: Atrophy
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was terminated early by the Sponsor because the compound had demonstrated to lack of efficacy. Thus, not all participants in this study completed the full duration of treatment.
point of contact: 