<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/NCT01709110</url>
  </required_header>
  <id_info>
    <org_study_id>14536</org_study_id>
    <secondary_id>B3D-EW-GHDW</secondary_id>
    <secondary_id>2012-000123-41</secondary_id>
    <nct_id>NCT01709110</nct_id>
  </id_info>
  <brief_title>VERtebral Fracture Treatment Comparisons in Osteoporotic Women</brief_title>
  <acronym>VERO</acronym>
  <official_title>Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of participation in this study is to answer whether teriparatide is&#xD;
      superior to risedronate in reducing the occurrence of new vertebral fractures during 24&#xD;
      months of therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>Phase 4</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>Proportion of Participants With New Vertebral Fractures</measure>
    <time_frame>Baseline through 24 Months</time_frame>
    <description>The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation.&#xD;
A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Pooled New and Worsening Vertebral Fractures</measure>
    <time_frame>Baseline through 24 Months</time_frame>
    <description>Worsening of a pre-existing fracture was considered if the decrease in vertebral height was at least one severity grade in the semi-quantitative assessment, confirmed by a trained central reader, where vertebrae were graded as normal (SQ0) or as with mild (SQ1), moderate (SQ2), or severe (SQ3) fractures, defined as ~20 to 25% (mild), ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 to L4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures</measure>
    <time_frame>Baseline through 24 Months</time_frame>
    <description>A clinical vertebral fracture was defined as a new or worsening vertebral fracture, confirmed by radiography, that was associated with signs and symptoms highly suggestive of a vertebral fracture.&#xD;
All non-vertebral fractures that occurred and were diagnosed between visits required the confirmation by the site investigators after evaluating the original x-ray film(s), the radiology or surgical report. For clinical vertebral fractures, the final confirmation of the diagnosis required the centralized evaluation by a trained, independent reader.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Non-Vertebral Fragility Fractures</measure>
    <time_frame>Baseline through 24 Months</time_frame>
    <description>A non-vertebral fracture is a fracture at any of the following non-vertebral sites: clavicle, scapula, ribs, sternum, sacrum, coccyx, humerus, radius, ulna, carpus, pelvis, hip, femur, patella, tibia, fibula, ankle, calcaneus, tarsus, and metatarsal. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object were not considered fragility fractures but traumatic fractures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Major Non-Vertebral Fragility Fractures</measure>
    <time_frame>Baseline through 24 Months</time_frame>
    <description>A major non-vertebral fracture is a fracture at any of the following non-vertebral sites hip, radius, humerus, ribs, pelvis, tibia and femur. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With New Moderate and/or Severe Vertebral Fractures</measure>
    <time_frame>Baseline through 24 Months</time_frame>
    <description>Vertebrae were graded as moderate (SQ2), or severe (SQ3) fractures, based on ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 through L4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With New Multiple (2 or More) Vertebral Fractures</measure>
    <time_frame>Baseline through 24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures</measure>
    <time_frame>Baseline through 24 Months</time_frame>
    <description>Traumatic fractures were considered if resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 24 Months Endpoint in Height</measure>
    <time_frame>Baseline, 24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale</measure>
    <time_frame>Baseline, 24 Months</time_frame>
    <description>Participants rated the worst back pain during the 24 hours preceding the visit at baseline and each post-baseline visit. An 11-point numerical back pain rating scale (rated from 0 = no back pain to 10 = worst possible back pain) was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)</measure>
    <time_frame>Baseline, 24 Months</time_frame>
    <description>The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.59 to 1.0. A higher score indicates better health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)</measure>
    <time_frame>Baseline, 24 Months</time_frame>
    <description>The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United States (US) cross walk algorithm, with scores ranging from -0.11 to 1.0. A higher score indicates better health state.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1366</enrollment>
  <condition>Postmenopausal Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Teriparatide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.&#xD;
Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Risedronate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Risedronate 35 milligram (mg) administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.&#xD;
Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teriparatide</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Teriparatide</arm_group_label>
    <other_name>LY333334</other_name>
    <other_name>Forteo</other_name>
    <other_name>Forsteo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risedronate</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Risedronate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Teriparatide arm placebo administered orally.&#xD;
Risedronate arm placebo administered SC.</description>
    <arm_group_label>Risedronate</arm_group_label>
    <arm_group_label>Teriparatide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Risedronate</arm_group_label>
    <arm_group_label>Teriparatide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Risedronate</arm_group_label>
    <arm_group_label>Teriparatide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal women with osteoporosis, as defined by low bone mineral density (BMD),&#xD;
             i.e. anterior-posterior lumbar spine, total hip or femoral neck BMD ≥1.5 standard&#xD;
             deviations below the average BMD for young, healthy, non-Hispanic, Caucasian women&#xD;
&#xD;
          -  A minimum of 2 moderate or 1 severe vertebral fragility fractures (confirmed by&#xD;
             central reader) were required&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Increased risk of osteosarcoma&#xD;
&#xD;
          -  History of unresolved skeletal diseases that affect bone metabolism&#xD;
&#xD;
          -  History of atypical subtrochanteric or diaphyseal femoral fractures&#xD;
&#xD;
          -  Abnormally high or low calcium levels&#xD;
&#xD;
          -  Abnormally high parathyroid hormone (PTH) levels&#xD;
&#xD;
          -  Severe vitamin D deficiency&#xD;
&#xD;
          -  Abnormal thyroid function not corrected by therapy&#xD;
&#xD;
          -  History of malignant neoplasms in the last 5 years&#xD;
&#xD;
          -  Active liver disease, clinical jaundice&#xD;
&#xD;
          -  Significant impairment of hepatic or renal function&#xD;
&#xD;
          -  History of nephro- or urolithiasis&#xD;
&#xD;
          -  Previous or planned kypho- or vertebroplasty&#xD;
&#xD;
          -  Active or risk for osteonecrosis of the jaw&#xD;
&#xD;
          -  Active or recent history of upper gastrointestinal disorders&#xD;
&#xD;
          -  Unable to stand or sit in the upright position for at least 30 minutes&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <zip>94520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Clifton</city>
        <state>New Jersey</state>
        <zip>07012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Freehold</city>
        <state>New Jersey</state>
        <zip>07728</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bend</city>
        <state>Oregon</state>
        <zip>97701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <state>British Columbia</state>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <state>Ontario</state>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>37005</zip>
        <country>Czechia</country>
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        <country>Czechia</country>
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        <country>Czechia</country>
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        <zip>14033</zip>
        <country>France</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>83260</zip>
        <country>France</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>69003</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>31059</zip>
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        <zip>60528</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>04103</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>39110</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>35043</zip>
        <country>Germany</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>10676</zip>
        <country>Greece</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <country>Greece</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>1094</zip>
        <country>Hungary</country>
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      <address>
        <city>Eger</city>
        <zip>3300</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Kaposvar</city>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Genova-Nervi</city>
        <zip>16167</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Orbassano</city>
        <zip>10043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Rome</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Valeggio Sul Mincio</city>
        <zip>37067</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bialystok</city>
        <zip>15-351</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Elblag</city>
        <zip>82-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lublin</city>
        <zip>20-582</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Poznan</city>
        <zip>60-218</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Swidnik</city>
        <zip>21-040</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Warsaw</city>
        <zip>02-118</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>San Juan</city>
        <zip>00918</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Alcira</city>
        <zip>46600</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Cadiz</city>
        <zip>11009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Sabadell</city>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <results_first_submitted>July 13, 2017</results_first_submitted>
  <results_first_submitted_qc>December 20, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">January 23, 2018</results_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bone Loss</keyword>
  <keyword>Vertebral fractures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Osteoporosis, Postmenopausal</mesh_term>
    <mesh_term>Spinal Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Teriparatide</mesh_term>
    <mesh_term>Risedronic Acid</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Teriparatide</title>
          <description>Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
        </group>
        <group group_id="P2">
          <title>Risedronate</title>
          <description>Risedronate 35 milligram (mg) administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="683"/>
                <participants group_id="P2" count="683"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="680"/>
                <participants group_id="P2" count="680"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="498"/>
                <participants group_id="P2" count="515"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="185"/>
                <participants group_id="P2" count="168"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
                <participants group_id="P2" count="89"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Caregiver Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Teriparatide</title>
          <description>Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
        </group>
        <group group_id="B2">
          <title>Risedronate</title>
          <description>Risedronate 35 milligram administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
        </group>
        <group group_id="B3">
          <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="680"/>
            <count group_id="B2" value="680"/>
            <count group_id="B3" value="1360"/>
          </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="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.6" spread="8.77"/>
                    <measurement group_id="B2" value="71.6" spread="8.58"/>
                    <measurement group_id="B3" value="72.1" spread="8.68"/>
                  </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="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="680"/>
                    <measurement group_id="B2" value="680"/>
                    <measurement group_id="B3" value="1360"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="203"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="310"/>
                    <measurement group_id="B2" value="302"/>
                    <measurement group_id="B3" value="612"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="266"/>
                    <measurement group_id="B2" value="279"/>
                    <measurement group_id="B3" value="545"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="670"/>
                    <measurement group_id="B2" value="653"/>
                    <measurement group_id="B3" value="1323"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Argentina</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czech Republic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Greece</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brazil</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Distribution of Stratification Factors</title>
          <description>A participant was considered as having a recent clinical vertebral fragility fracture if she had at least one clinical vertebral fragility fracture within the last 12 months prior to baseline. A participant was considered a recent prior bisphosphonate user if she had received a total of 6 or more months of treatment with any oral bisphosphonate within 3 years prior to baseline.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Vertebral Fracture with Bisphosphonate Use</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>With Vertebral Fracture without Bisphosphonate Use</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="170"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="335"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Vertebral Fracture with Bisphosphonate Use</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="184"/>
                    <measurement group_id="B2" value="189"/>
                    <measurement group_id="B3" value="373"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Vertebral Fracture without Bisphosphonate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="244"/>
                    <measurement group_id="B2" value="247"/>
                    <measurement group_id="B3" value="491"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Bone Mineral Density (BMD)</title>
          <description>Low BMD is defined as an lumbar spine, total hip or femoral neck BMD ≥ 1.5 standard deviation (SD) below the average BMD for young healthy, non-Hispanic, Caucasian women. Lumbar spine, total hip and femoral neck BMD were assessed by DXA by the investigator at baseline.</description>
          <population>Any lumbar vertebrae that were not analyzed due to artifacts, fracture, osteophytes, or other abnormalities, should be excluded from the analysis.</population>
          <units>Gram per square centimeter (g/cm2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Lumbar Spine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="644"/>
                    <count group_id="B2" value="653"/>
                    <count group_id="B3" value="1297"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.858" spread="0.1541"/>
                    <measurement group_id="B2" value="0.856" spread="0.1473"/>
                    <measurement group_id="B3" value="0.857" spread="0.1506"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Femoral Neck</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="658"/>
                    <count group_id="B2" value="656"/>
                    <count group_id="B3" value="1314"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.662" spread="0.1085"/>
                    <measurement group_id="B2" value="0.667" spread="0.1129"/>
                    <measurement group_id="B3" value="0.664" spread="0.1107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Hip</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="633"/>
                    <count group_id="B2" value="640"/>
                    <count group_id="B3" value="1273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.736" spread="0.1065"/>
                    <measurement group_id="B2" value="0.735" spread="0.1165"/>
                    <measurement group_id="B3" value="0.735" spread="0.1116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Vertebral Fracture Status</title>
          <description>(according to Bioclinica spine x-ray central assessment at baseline).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>1 Fracture</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="231"/>
                    <measurement group_id="B2" value="240"/>
                    <measurement group_id="B3" value="471"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Fractures</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="178"/>
                    <measurement group_id="B2" value="174"/>
                    <measurement group_id="B3" value="352"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Fractures</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Fractures</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 or More Fractures</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="680"/>
                    <count group_id="B2" value="680"/>
                    <count group_id="B3" value="1360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Participants With New Vertebral Fractures</title>
        <description>The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation.&#xD;
A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture.</description>
        <time_frame>Baseline through 24 Months</time_frame>
        <population>Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.</population>
        <group_list>
          <group group_id="O1">
            <title>Teriparatide</title>
            <description>Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Risedronate 35 milligram administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With New Vertebral Fractures</title>
          <description>The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation.&#xD;
A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture.</description>
          <population>Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.</population>
          <units>Participants (with at least one event)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="516"/>
                <count group_id="O2" value="533"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.000094</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.4071</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.256</ci_lower_limit>
            <ci_upper_limit>0.647</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.000094</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.</method_desc>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.4431</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.290</ci_lower_limit>
            <ci_upper_limit>0.677</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Pooled New and Worsening Vertebral Fractures</title>
        <description>Worsening of a pre-existing fracture was considered if the decrease in vertebral height was at least one severity grade in the semi-quantitative assessment, confirmed by a trained central reader, where vertebrae were graded as normal (SQ0) or as with mild (SQ1), moderate (SQ2), or severe (SQ3) fractures, defined as ~20 to 25% (mild), ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 to L4).</description>
        <time_frame>Baseline through 24 Months</time_frame>
        <population>Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.</population>
        <group_list>
          <group group_id="O1">
            <title>Teriparatide</title>
            <description>Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Risedronate 35 milligram administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Pooled New and Worsening Vertebral Fractures</title>
          <description>Worsening of a pre-existing fracture was considered if the decrease in vertebral height was at least one severity grade in the semi-quantitative assessment, confirmed by a trained central reader, where vertebrae were graded as normal (SQ0) or as with mild (SQ1), moderate (SQ2), or severe (SQ3) fractures, defined as ~20 to 25% (mild), ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 to L4).</description>
          <population>Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.</population>
          <units>Participants (with at least one event)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="516"/>
                <count group_id="O2" value="533"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.000075</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.4187</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.269</ci_lower_limit>
            <ci_upper_limit>0.652</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.000075</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.</method_desc>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.4561</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.305</ci_lower_limit>
            <ci_upper_limit>0.682</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures</title>
        <description>A clinical vertebral fracture was defined as a new or worsening vertebral fracture, confirmed by radiography, that was associated with signs and symptoms highly suggestive of a vertebral fracture.&#xD;
All non-vertebral fractures that occurred and were diagnosed between visits required the confirmation by the site investigators after evaluating the original x-ray film(s), the radiology or surgical report. For clinical vertebral fractures, the final confirmation of the diagnosis required the centralized evaluation by a trained, independent reader.</description>
        <time_frame>Baseline through 24 Months</time_frame>
        <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Teriparatide</title>
            <description>Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Risedronate 35 milligram administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures</title>
          <description>A clinical vertebral fracture was defined as a new or worsening vertebral fracture, confirmed by radiography, that was associated with signs and symptoms highly suggestive of a vertebral fracture.&#xD;
All non-vertebral fractures that occurred and were diagnosed between visits required the confirmation by the site investigators after evaluating the original x-ray film(s), the radiology or surgical report. For clinical vertebral fractures, the final confirmation of the diagnosis required the centralized evaluation by a trained, independent reader.</description>
          <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
          <units>Participants (with at least one event)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="680"/>
                <count group_id="O2" value="680"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.000869</p_value>
            <method>Stratified Log Rank</method>
            <method_desc>Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.</method_desc>
            <param_type>Stratified Hazard Ratio (HR)</param_type>
            <param_value>0.4831</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.316</ci_lower_limit>
            <ci_upper_limit>0.739</ci_upper_limit>
            <estimate_desc>The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Non-Vertebral Fragility Fractures</title>
        <description>A non-vertebral fracture is a fracture at any of the following non-vertebral sites: clavicle, scapula, ribs, sternum, sacrum, coccyx, humerus, radius, ulna, carpus, pelvis, hip, femur, patella, tibia, fibula, ankle, calcaneus, tarsus, and metatarsal. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object were not considered fragility fractures but traumatic fractures.</description>
        <time_frame>Baseline through 24 Months</time_frame>
        <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Teriparatide</title>
            <description>Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Risedronate 35 milligram administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Non-Vertebral Fragility Fractures</title>
          <description>A non-vertebral fracture is a fracture at any of the following non-vertebral sites: clavicle, scapula, ribs, sternum, sacrum, coccyx, humerus, radius, ulna, carpus, pelvis, hip, femur, patella, tibia, fibula, ankle, calcaneus, tarsus, and metatarsal. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object were not considered fragility fractures but traumatic fractures.</description>
          <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
          <units>Participants (with at least one event)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="680"/>
                <count group_id="O2" value="680"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.099023</p_value>
            <method>Stratified Log Rank</method>
            <method_desc>Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.</method_desc>
            <param_type>Stratified Hazard Ratio (HR)</param_type>
            <param_value>0.6553</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.390</ci_lower_limit>
            <ci_upper_limit>1.101</ci_upper_limit>
            <estimate_desc>The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Major Non-Vertebral Fragility Fractures</title>
        <description>A major non-vertebral fracture is a fracture at any of the following non-vertebral sites hip, radius, humerus, ribs, pelvis, tibia and femur. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving.</description>
        <time_frame>Baseline through 24 Months</time_frame>
        <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Teriparatide</title>
            <description>Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Risedronate 35 milligram administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Major Non-Vertebral Fragility Fractures</title>
          <description>A major non-vertebral fracture is a fracture at any of the following non-vertebral sites hip, radius, humerus, ribs, pelvis, tibia and femur. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving.</description>
          <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
          <units>Participants (with at least one event)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="680"/>
                <count group_id="O2" value="680"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.062432</p_value>
            <method>Stratified Log Rank</method>
            <method_desc>Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.</method_desc>
            <param_type>Stratified Hazard Ratio (HR)</param_type>
            <param_value>0.5786</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.318</ci_lower_limit>
            <ci_upper_limit>1.052</ci_upper_limit>
            <estimate_desc>The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With New Moderate and/or Severe Vertebral Fractures</title>
        <description>Vertebrae were graded as moderate (SQ2), or severe (SQ3) fractures, based on ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 through L4).</description>
        <time_frame>Baseline through 24 Months</time_frame>
        <population>Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.</population>
        <group_list>
          <group group_id="O1">
            <title>Teriparatide</title>
            <description>Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Risedronate 35 milligram administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With New Moderate and/or Severe Vertebral Fractures</title>
          <description>Vertebrae were graded as moderate (SQ2), or severe (SQ3) fractures, based on ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 through L4).</description>
          <population>Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.</population>
          <units>Participants (with at least one event)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="516"/>
                <count group_id="O2" value="533"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.3812</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.237</ci_lower_limit>
            <ci_upper_limit>0.614</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.</method_desc>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.4173</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.270</ci_lower_limit>
            <ci_upper_limit>0.646</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With New Multiple (2 or More) Vertebral Fractures</title>
        <time_frame>Baseline through 24 Months</time_frame>
        <population>Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.</population>
        <group_list>
          <group group_id="O1">
            <title>Teriparatide</title>
            <description>Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Risedronate 35 milligram administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With New Multiple (2 or More) Vertebral Fractures</title>
          <population>Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.</population>
          <units>Participants (with at least one event)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="516"/>
                <count group_id="O2" value="533"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.007</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.1593</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.035</ci_lower_limit>
            <ci_upper_limit>0.728</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.007</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.</method_desc>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.1643</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.036</ci_lower_limit>
            <ci_upper_limit>0.744</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures</title>
        <description>Traumatic fractures were considered if resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object.</description>
        <time_frame>Baseline through 24 Months</time_frame>
        <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Teriparatide</title>
            <description>Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Risedronate 35 milligram administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures</title>
          <description>Traumatic fractures were considered if resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object.</description>
          <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
          <units>Participants (with at least one event)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="680"/>
                <count group_id="O2" value="680"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.078</p_value>
            <method>Stratified Log Rank</method>
            <method_desc>Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.</method_desc>
            <param_type>Stratified Hazard Ratio (HR)</param_type>
            <param_value>0.6960</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.461</ci_lower_limit>
            <ci_upper_limit>1.050</ci_upper_limit>
            <estimate_desc>The Stratified Hazard Ratio estimates and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 24 Months Endpoint in Height</title>
        <time_frame>Baseline, 24 Months</time_frame>
        <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Teriparatide</title>
            <description>Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Risedronate 35 milligram administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 24 Months Endpoint in Height</title>
          <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
          <units>Centimeter (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="565"/>
                <count group_id="O2" value="580"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154.7" spread="7.15"/>
                    <measurement group_id="O2" value="155.0" spread="7.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154.3" spread="7.05"/>
                    <measurement group_id="O2" value="154.5" spread="7.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.093</p_value>
            <p_value_desc>Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline body height(cm).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.</method_desc>
            <param_type>Least Squares Mean</param_type>
            <param_value>-0.13</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.08</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.28</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
            <estimate_desc>Treatment difference was calculated as Teriparatide - Risedronate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale</title>
        <description>Participants rated the worst back pain during the 24 hours preceding the visit at baseline and each post-baseline visit. An 11-point numerical back pain rating scale (rated from 0 = no back pain to 10 = worst possible back pain) was used.</description>
        <time_frame>Baseline, 24 Months</time_frame>
        <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Teriparatide</title>
            <description>Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Risedronate 35 milligram administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale</title>
          <description>Participants rated the worst back pain during the 24 hours preceding the visit at baseline and each post-baseline visit. An 11-point numerical back pain rating scale (rated from 0 = no back pain to 10 = worst possible back pain) was used.</description>
          <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="642"/>
                <count group_id="O2" value="648"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="2.90"/>
                    <measurement group_id="O2" value="4.5" spread="2.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="2.95"/>
                    <measurement group_id="O2" value="3.4" spread="2.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.585</p_value>
            <p_value_desc>Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline back pain (no pain - worst pain [0-10]).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.</method_desc>
            <param_type>Least Squares Mean</param_type>
            <param_value>-0.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.42</ci_lower_limit>
            <ci_upper_limit>0.24</ci_upper_limit>
            <estimate_desc>Treatment difference was calculated as Teriparatide - Risedronate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)</title>
        <description>The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.59 to 1.0. A higher score indicates better health state.</description>
        <time_frame>Baseline, 24 Months</time_frame>
        <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Teriparatide</title>
            <description>Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Risedronate 35 milligram administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)</title>
          <description>The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.59 to 1.0. A higher score indicates better health state.</description>
          <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="642"/>
                <count group_id="O2" value="647"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.59" spread="0.243"/>
                    <measurement group_id="O2" value="0.62" spread="0.228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.65" spread="0.249"/>
                    <measurement group_id="O2" value="0.68" spread="0.205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.757</p_value>
            <p_value_desc>Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (UK).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.</method_desc>
            <param_type>Least Squares Mean</param_type>
            <param_value>-0.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.01</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.03</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
            <estimate_desc>Treatment difference was calculated as Teriparatide - Risedronate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)</title>
        <description>The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United States (US) cross walk algorithm, with scores ranging from -0.11 to 1.0. A higher score indicates better health state.</description>
        <time_frame>Baseline, 24 Months</time_frame>
        <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Teriparatide</title>
            <description>Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Risedronate</title>
            <description>Risedronate 35 milligram administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)</title>
          <description>The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United States (US) cross walk algorithm, with scores ranging from -0.11 to 1.0. A higher score indicates better health state.</description>
          <population>Full analysis set: all participants who received at least one dose of study drug and had evaluable data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="642"/>
                <count group_id="O2" value="647"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70" spread="0.167"/>
                    <measurement group_id="O2" value="0.72" spread="0.159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.74" spread="0.176"/>
                    <measurement group_id="O2" value="0.76" spread="0.145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.694</p_value>
            <p_value_desc>Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (US).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.</method_desc>
            <param_type>Least Squares Mean</param_type>
            <param_value>-0.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.01</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.02</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
            <estimate_desc>Treatment difference was calculated as Teriparatide - Risedronate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Teriparatide</title>
          <description>Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.&#xD;
Placebo given orally once weekly for 24 months.</description>
        </group>
        <group group_id="E2">
          <title>Risedronate</title>
          <description>Risedronate 35 milligram administered orally once weekly for 24 months.&#xD;
Placebo given by SC injection once daily for 24 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="138" subjects_at_risk="683"/>
                <counts group_id="E2" subjects_affected="117" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Haemolytic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Immune thrombocytopenic purpura</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Microcytic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Pernicious anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="683"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Cardiac valve disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Tricuspid valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Left ventricle outflow tract obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Femoral hernia, obstructive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Oesophageal achalasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Pancreatic cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Regurgitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Performance status decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Ischaemic hepatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Escherichia pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="683"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Pyonephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Cervical vertebral fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="683"/>
                <counts group_id="E2" events="21" subjects_affected="19" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="683"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="683"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="683"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Incisional hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="683"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Patella fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Post procedural stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Procedural nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Procedural vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="683"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Scapula fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Subcutaneous haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" events="6" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Ulna fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Carbohydrate antigen 19-9 increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>General physical condition abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="683"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Kyphosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Osteitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="683"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Periostitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Pseudarthrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Tendon disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Vertebral foraminal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Breast cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Breast neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Cervix carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Chondrosarcoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Cystadenocarcinoma ovary</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Endometrial cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Hypergammaglobulinaemia benign monoclonal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Invasive breast carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Laryngeal cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Lung neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Non-small cell lung cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Ovarian cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Papillary thyroid cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Cerebellar ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Cerebral artery embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Intercostal neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Radicular pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Vascular dementia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Vascular encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol abuse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Nephrotic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Female genital tract fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Uterine prolapse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </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" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Chronic respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Laryngospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </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" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Systemic lupus erythematosus rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Arterial disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="683"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Granulomatosis with polyangiitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Subclavian artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Vena cava thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="683"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="130" subjects_at_risk="683"/>
                <counts group_id="E2" subjects_affected="130" subjects_at_risk="683"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="54" subjects_affected="44" subjects_at_risk="683"/>
                <counts group_id="E2" events="63" subjects_affected="51" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="77" subjects_affected="73" subjects_at_risk="683"/>
                <counts group_id="E2" events="89" subjects_affected="79" subjects_at_risk="683"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="45" subjects_affected="37" subjects_at_risk="683"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="683"/>
              </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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </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/NCT01709110
org study id: 14536
secondary id: B3D-EW-GHDW
secondary id: 2012-000123-41
nct id: NCT01709110
lead sponsor: 
has dmc: No
The primary purpose of participation in this study is to answer whether teriparatide is
      superior to risedronate in reducing the occurrence of new vertebral fractures during 24
      months of therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Proportion of Participants With New Vertebral Fractures
time frame: Baseline through 24 Months
description: The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation.
A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture.
measure: Proportion of Participants With Pooled New and Worsening Vertebral Fractures
time frame: Baseline through 24 Months
description: Worsening of a pre-existing fracture was considered if the decrease in vertebral height was at least one severity grade in the semi-quantitative assessment, confirmed by a trained central reader, where vertebrae were graded as normal (SQ0) or as with mild (SQ1), moderate (SQ2), or severe (SQ3) fractures, defined as ~20 to 25% (mild), ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 to L4).
measure: Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures
time frame: Baseline through 24 Months
description: A clinical vertebral fracture was defined as a new or worsening vertebral fracture, confirmed by radiography, that was associated with signs and symptoms highly suggestive of a vertebral fracture.
All non-vertebral fractures that occurred and were diagnosed between visits required the confirmation by the site investigators after evaluating the original x-ray film(s), the radiology or surgical report. For clinical vertebral fractures, the final confirmation of the diagnosis required the centralized evaluation by a trained, independent reader.
measure: Proportion of Participants With Non-Vertebral Fragility Fractures
time frame: Baseline through 24 Months
description: A non-vertebral fracture is a fracture at any of the following non-vertebral sites: clavicle, scapula, ribs, sternum, sacrum, coccyx, humerus, radius, ulna, carpus, pelvis, hip, femur, patella, tibia, fibula, ankle, calcaneus, tarsus, and metatarsal. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object were not considered fragility fractures but traumatic fractures.
measure: Proportion of Participants With Major Non-Vertebral Fragility Fractures
time frame: Baseline through 24 Months
description: A major non-vertebral fracture is a fracture at any of the following non-vertebral sites hip, radius, humerus, ribs, pelvis, tibia and femur. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving.
measure: Proportion of Participants With New Moderate and/or Severe Vertebral Fractures
time frame: Baseline through 24 Months
description: Vertebrae were graded as moderate (SQ2), or severe (SQ3) fractures, based on ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 through L4).
measure: Proportion of Participants With New Multiple (2 or More) Vertebral Fractures
time frame: Baseline through 24 Months
measure: Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures
time frame: Baseline through 24 Months
description: Traumatic fractures were considered if resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object.
measure: Change From Baseline to 24 Months Endpoint in Height
time frame: Baseline, 24 Months
measure: Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale
time frame: Baseline, 24 Months
description: Participants rated the worst back pain during the 24 hours preceding the visit at baseline and each post-baseline visit. An 11-point numerical back pain rating scale (rated from 0 = no back pain to 10 = worst possible back pain) was used.
measure: Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)
time frame: Baseline, 24 Months
description: The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.59 to 1.0. A higher score indicates better health state.
measure: Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)
time frame: Baseline, 24 Months
description: The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United States (US) cross walk algorithm, with scores ranging from -0.11 to 1.0. A higher score indicates better health state.
arm group label: Teriparatide
arm group type: Experimental
description: Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment.
arm group label: Risedronate
arm group type: Active Comparator
description: Risedronate 35 milligram (mg) administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment.
intervention type: Drug
intervention name: Teriparatide
description: Administered SC
arm group label: Teriparatide
other name: LY333334
other name: Forteo
other name: Forsteo
intervention type: Drug
intervention name: Risedronate
description: Administered orally
arm group label: Risedronate
intervention type: Drug
intervention name: Placebo
description: Teriparatide arm placebo administered orally.
Risedronate arm placebo administered SC.
arm group label: Risedronate
arm group label: Teriparatide
intervention type: Drug
intervention name: Calcium
description: Administered orally
arm group label: Risedronate
arm group label: Teriparatide
intervention type: Drug
intervention name: Vitamin D
description: Administered orally
arm group label: Risedronate
arm group label: Teriparatide
criteria: 
gender: Female
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Argentina
country: Austria
country: Belgium
country: Brazil
country: Canada
country: Czechia
country: France
country: Germany
country: Greece
country: Hungary
country: Italy
country: Poland
country: Puerto Rico
country: Spain
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Osteoporosis, Postmenopausal
mesh term: Spinal Fractures
mesh term: Vitamin D
mesh term: Teriparatide
mesh term: Risedronic Acid
mesh term: Calcium
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://vivli.org/
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 