<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/NCT03018938</url>
  </required_header>
  <id_info>
    <org_study_id>16507</org_study_id>
    <secondary_id>F3Z-GH-IOQR</secondary_id>
    <nct_id>NCT03018938</nct_id>
  </id_info>
  <brief_title>A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus</brief_title>
  <acronym>CLASSIC</acronym>
  <official_title>Comparison Between Basal Insulin Analog and Insulin Analog Mid Mixture AS Starter Insulin for Chinese Patients With Type 2 Diabetes Mellitus (CLASSIC Study)</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effectiveness of basal insulin analog and insulin&#xD;
      analog mid mixture in Chinese participants with type 2 diabetes mellitus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">July 12, 2019</completion_date>
  <primary_completion_date type="Actual">February 19, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)</measure>
    <time_frame>Baseline, 24 Weeks</time_frame>
    <description>HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.&#xD;
Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 48 in HbA1c</measure>
    <time_frame>Baseline, 48 Weeks</time_frame>
    <description>HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.&#xD;
Least Squares (LS) mean was determined by ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieve HbA1c &lt;7% at Week 24</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieve HbA1c &lt;7% at Week 48</measure>
    <time_frame>48 Weeks</time_frame>
    <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 24 in Venous Fasting Plasma Glucose</measure>
    <time_frame>Baseline, 24 Weeks</time_frame>
    <description>Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 48 in Venous Fasting Plasma Glucose</measure>
    <time_frame>Baseline, 48 Weeks</time_frame>
    <description>Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose</measure>
    <time_frame>Baseline, 24 Weeks</time_frame>
    <description>Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose</measure>
    <time_frame>Baseline, 48 Weeks</time_frame>
    <description>Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Daily Insulin Dose at Week 24 and 48</measure>
    <time_frame>24 Weeks, 48 Weeks</time_frame>
    <description>Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 24 in Body Weight</measure>
    <time_frame>Baseline, 24 Weeks</time_frame>
    <description>LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 48 in Body Weight</measure>
    <time_frame>Baseline, 48 Weeks</time_frame>
    <description>LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Hypoglycemia at Week 24 and 48</measure>
    <time_frame>24 Weeks, 48 Weeks</time_frame>
    <description>Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25) as an offset variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Insulin Treatment Change at Week 48</measure>
    <time_frame>Baseline through 48 Weeks</time_frame>
    <description>Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency.&#xD;
Discontinuation: Defined as stopping insulin treatment for 30 days or more.&#xD;
Switch: Defined as stop the initial insulin therapy and started another insulin therapy of different class.&#xD;
Intensification: Defined as any of the following: adding meal time insulin in basal insulin analog QD group; changing from BID to TID (Three times a day) in insulin analog mid mixture BID group&#xD;
Reduction in frequency: Defined as any of the following: changing from BID to QD; changing from TID to BID or QD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieve the HbA1c &lt;7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of &lt;7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieve the HbA1c &lt;7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48</measure>
    <time_frame>48 Weeks</time_frame>
    <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of &lt;7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score</measure>
    <time_frame>Baseline, 48 Weeks</time_frame>
    <description>The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy. The SEITQ consists of 5 items (that is, statements). The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications. Each item score ranges from 1 (strongly disagree) to 7 (strongly agree). The total SEITQ score is the sum of each item scores, with the range of 5 to 35. Higher SEITQ score indicates better outcome (higher self-efficacy). LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">814</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Insulin Analog Mid Mixture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insulin analog mid mixture given subcutaneously (SC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Basal Insulin Analog</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Basal insulin analog given SC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin Analog Mid Mixture</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Insulin Analog Mid Mixture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Basal Insulin Analog</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Basal Insulin Analog</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have type 2 diabetes as defined by World Health Organization (WHO) criteria&#xD;
&#xD;
          -  are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by&#xD;
             the investigator&#xD;
&#xD;
          -  most recent HbA1c value ≥7.5% within 12 weeks of study entry&#xD;
&#xD;
          -  in the opinion of the investigator, require to initiate premix analog or basal insulin&#xD;
             analog treatment&#xD;
&#xD;
          -  willing to start with insulin treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have a diagnosis of type 1 diabetes&#xD;
&#xD;
          -  have received any type of insulin within 24 months of study entry (except for&#xD;
             intermittent use of insulin of less than 1 month each time)&#xD;
&#xD;
          -  have serious preexisting medical or other conditions that, in the judgment of the&#xD;
             investigator, would preclude participation in this study&#xD;
&#xD;
          -  are pregnant or breastfeeding, or intend to become pregnant during the course of the&#xD;
             study&#xD;
&#xD;
          -  are currently enrolled or have participated, within the last 30 days in any other&#xD;
             clinical trial involving an investigational product or any other type of medical&#xD;
             research judged not to be scientifically or medically compatible&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Huaxin Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Peoples Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Meitan General Hospital</name>
      <address>
        <city>Chaoyang</city>
        <state>Beijing</state>
        <zip>100028</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Yanhua hospital</name>
      <address>
        <city>Fangshan</city>
        <state>Beijing</state>
        <zip>102500</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 2nd Hospital of Lanzhou University</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenzhen City People Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 1st Hospital with Guangdong Pharmaceutical University</name>
      <address>
        <city>Yuexiu</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 1st Affiliated Hospital of Henan Science and technology</name>
      <address>
        <city>Luoyang</city>
        <state>Henan</state>
        <zip>471003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Henan Province</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuhan Union (Xiehe) Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changzhou No.2 People's Hospital</name>
      <address>
        <city>Changzhou</city>
        <state>Jiangsu</state>
        <zip>213003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing TCM hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiang Su Province Official Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210024</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing Jiangbei Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210048</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing Jiangning Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>211100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taizhou City People Hospital</name>
      <address>
        <city>Taizhou</city>
        <state>Jiangsu</state>
        <zip>225300</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The second People's hospital of Wuxi</name>
      <address>
        <city>Wuxi</city>
        <state>Jiangsu</state>
        <zip>214000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xuzhou central Hospital</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <zip>221009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qingdao Municipal Hospital</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taian City Central Hospital</name>
      <address>
        <city>Taian</city>
        <state>Shandong</state>
        <zip>271000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Pudong New Area Gongli Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200135</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Pudong New District Zhoupu Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>201318</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of North Sichuan Medical College</name>
      <address>
        <city>Nanchong</city>
        <state>Shunqing</state>
        <zip>637000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Affiliated Hospital of Chengdu University of TCM</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Medical University Affiliated Hospital</name>
      <address>
        <city>Luzhou</city>
        <state>Sichuan</state>
        <zip>646000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin First Central Hospital</name>
      <address>
        <city>Nankai</city>
        <state>Tianjin</state>
        <zip>300192</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing LuHe Hospital Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Tongzhou</state>
        <zip>101149</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Provincial People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ningbo First Hospital</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University International Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>102206</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Hai Dian Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Yangpu District Central Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200090</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 15, 2019</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <results_first_submitted>January 31, 2020</results_first_submitted>
  <results_first_submitted_qc>March 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 18, 2020</results_first_posted>
  <last_update_submitted>March 6, 2020</last_update_submitted>
  <last_update_submitted_qc>March 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mid mixture insulin analog</keyword>
  <keyword>basal insulin analog</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 26, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03018938/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03018938/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Insulin Analog Mid Mixture</title>
          <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
        </group>
        <group group_id="P2">
          <title>Basal Insulin Analog</title>
          <description>Participants received Basal insulin analog given subcutaneously (SC) once daily (QD) at the discretion of the investigator.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="404"/>
                <participants group_id="P2" count="410"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="404"/>
                <participants group_id="P2" count="410"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="338"/>
                <participants group_id="P2" count="325"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="85"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screen failure-After randomization</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not recorded</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants who received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Insulin Analog Mid Mixture</title>
          <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
        </group>
        <group group_id="B2">
          <title>Basal Insulin Analog</title>
          <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</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="404"/>
            <count group_id="B2" value="410"/>
            <count group_id="B3" value="814"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.8" spread="9.08"/>
                    <measurement group_id="B2" value="57.5" spread="9.29"/>
                    <measurement group_id="B3" value="57.6" spread="9.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="181"/>
                    <measurement group_id="B2" value="177"/>
                    <measurement group_id="B3" value="358"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="223"/>
                    <measurement group_id="B2" value="233"/>
                    <measurement group_id="B3" value="456"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="404"/>
                    <measurement group_id="B2" value="410"/>
                    <measurement group_id="B3" value="814"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="404"/>
                    <measurement group_id="B2" value="410"/>
                    <measurement group_id="B3" value="814"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</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>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_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>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="404"/>
                    <measurement group_id="B2" value="410"/>
                    <measurement group_id="B3" value="814"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin A1c (HbA1c)</title>
          <description>HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.</description>
          <units>Percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.937" spread="1.6509"/>
                    <measurement group_id="B2" value="9.696" spread="1.5619"/>
                    <measurement group_id="B3" value="9.816" spread="1.6104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)</title>
        <description>HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.&#xD;
Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.</description>
        <time_frame>Baseline, 24 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)</title>
          <description>HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.&#xD;
Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c.</population>
          <units>Percentage of HbA1c</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="322"/>
                <count group_id="O2" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.158" spread="0.0675"/>
                    <measurement group_id="O2" value="-2.000" spread="0.0678"/>
                  </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>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>If Lower limit (L) &gt;-0.4%, the Non-inferiority (NI) of basal insulin analog QD to insulin analog mid mixture BID is established; If Upper limit (U) &lt;0.4%, the NI of insulin analog mid mixture BID to basal insulin analog QD is established</non_inferiority_desc>
            <p_value>0.1009</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.158</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0959</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.346</ci_lower_limit>
            <ci_upper_limit>0.031</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 48 in HbA1c</title>
        <description>HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.&#xD;
Least Squares (LS) mean was determined by ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.</description>
        <time_frame>Baseline, 48 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 48 in HbA1c</title>
          <description>HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.&#xD;
Least Squares (LS) mean was determined by ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c.</population>
          <units>Percentage of HbA1c</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="338"/>
                <count group_id="O2" value="342"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.029" spread="0.0631"/>
                    <measurement group_id="O2" value="-1.829" spread="0.0627"/>
                  </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>0.0246</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.201</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0891</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.376</ci_lower_limit>
            <ci_upper_limit>-0.026</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieve HbA1c &lt;7% at Week 24</title>
        <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.</description>
        <time_frame>24 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c &lt;7%.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieve HbA1c &lt;7% at Week 24</title>
          <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c &lt;7%.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="404"/>
                <count group_id="O2" value="410"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.9"/>
                    <measurement group_id="O2" value="28.3"/>
                  </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>0.0941</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>1.87</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieve HbA1c &lt;7% at Week 48</title>
        <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.</description>
        <time_frame>48 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c &lt;7%.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieve HbA1c &lt;7% at Week 48</title>
          <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c &lt;7%.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="404"/>
                <count group_id="O2" value="410"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3"/>
                    <measurement group_id="O2" value="23.4"/>
                  </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>0.8592</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.49</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 24 in Venous Fasting Plasma Glucose</title>
        <description>Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.</description>
        <time_frame>Baseline, 24 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Venous Fasting Plasma Glucose.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24 in Venous Fasting Plasma Glucose</title>
          <description>Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Venous Fasting Plasma Glucose.</population>
          <units>millimole/liter (mmol/L)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="282"/>
                <count group_id="O2" value="285"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.332" spread="0.1525"/>
                    <measurement group_id="O2" value="-2.755" spread="0.1517"/>
                  </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>0.0497</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>0.423</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2152</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.000</ci_lower_limit>
            <ci_upper_limit>0.846</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 48 in Venous Fasting Plasma Glucose</title>
        <description>Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.</description>
        <time_frame>Baseline, 48 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Venous Fasting Plasma Glucose.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 48 in Venous Fasting Plasma Glucose</title>
          <description>Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Venous Fasting Plasma Glucose.</population>
          <units>millimole/liter (mmol/L)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="302"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.527" spread="0.1391"/>
                    <measurement group_id="O2" value="-3.174" spread="0.1373"/>
                  </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>0.0010</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>0.647</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1955</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.263</ci_lower_limit>
            <ci_upper_limit>1.031</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose</title>
        <description>Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.</description>
        <time_frame>Baseline, 24 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for FBG and PPG.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose</title>
          <description>Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for FBG and PPG.</population>
          <units>mmol/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="210"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FBG</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="210"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.105" spread="0.1544"/>
                    <measurement group_id="O2" value="-2.374" spread="0.1551"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PPG</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="206"/>
                    <count group_id="O2" value="202"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.184" spread="0.2344"/>
                    <measurement group_id="O2" value="-4.101" spread="0.2367"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>FBG</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2193</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>0.270</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2191</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.161</ci_lower_limit>
            <ci_upper_limit>0.700</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>PPG</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8014</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.084</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.3331</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.739</ci_lower_limit>
            <ci_upper_limit>0.571</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose</title>
        <description>Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.</description>
        <time_frame>Baseline, 48 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for FBG and PPG.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose</title>
          <description>Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for FBG and PPG.</population>
          <units>mmol/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="237"/>
                <count group_id="O2" value="232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FBG</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="237"/>
                    <count group_id="O2" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.233" spread="0.1429"/>
                    <measurement group_id="O2" value="-2.724" spread="0.1444"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PPG</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.372" spread="0.2129"/>
                    <measurement group_id="O2" value="-4.359" spread="0.2153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>FBG</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0160</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>0.491</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2033</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.092</ci_lower_limit>
            <ci_upper_limit>0.891</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>PPG</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9661</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.013</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.3028</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.608</ci_lower_limit>
            <ci_upper_limit>0.582</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Daily Insulin Dose at Week 24 and 48</title>
        <description>Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.</description>
        <time_frame>24 Weeks, 48 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Daily Insulin Dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Daily Insulin Dose at Week 24 and 48</title>
          <description>Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Daily Insulin Dose.</population>
          <units>International Units (IU) per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="331"/>
                <count group_id="O2" value="325"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24 Weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="331"/>
                    <count group_id="O2" value="325"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.89" spread="10.245"/>
                    <measurement group_id="O2" value="14.58" spread="7.093"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 Weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="325"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.22" spread="11.238"/>
                    <measurement group_id="O2" value="15.35" spread="7.090"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 24 in Body Weight</title>
        <description>LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.</description>
        <time_frame>Baseline, 24 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Body Weight.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24 in Body Weight</title>
          <description>LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Body Weight.</population>
          <units>kilograms (kg)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="356"/>
                <count group_id="O2" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.226" spread="0.1976"/>
                    <measurement group_id="O2" value="0.559" spread="0.1949"/>
                  </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>0.0166</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.667</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2776</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.122</ci_lower_limit>
            <ci_upper_limit>1.211</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 48 in Body Weight</title>
        <description>LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.</description>
        <time_frame>Baseline, 48 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Body Weight.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 48 in Body Weight</title>
          <description>LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Body Weight.</population>
          <units>kilograms (kg)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="359"/>
                <count group_id="O2" value="368"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.393" spread="0.2037"/>
                    <measurement group_id="O2" value="0.639" spread="0.2012"/>
                  </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>0.0086</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>0.754</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2864</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.192</ci_lower_limit>
            <ci_upper_limit>1.316</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Hypoglycemia at Week 24 and 48</title>
        <description>Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25) as an offset variable.</description>
        <time_frame>24 Weeks, 48 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Hypoglycemia.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Hypoglycemia at Week 24 and 48</title>
          <description>Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25) as an offset variable.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Hypoglycemia.</population>
          <units>Events/Participant/Year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Nocturnal Hypoglycemia (24 Weeks)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="3.128"/>
                    <measurement group_id="O2" value="0.24" spread="0.955"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nocturnal Hypoglycemia (48 Weeks)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="1.931"/>
                    <measurement group_id="O2" value="0.20" spread="0.753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Hypoglycemia (24 Weeks)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.60" spread="5.076"/>
                    <measurement group_id="O2" value="0.63" spread="1.785"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Hypoglycemia (48 Weeks)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" spread="3.831"/>
                    <measurement group_id="O2" value="0.45" spread="1.188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Insulin Treatment Change at Week 48</title>
        <description>Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency.&#xD;
Discontinuation: Defined as stopping insulin treatment for 30 days or more.&#xD;
Switch: Defined as stop the initial insulin therapy and started another insulin therapy of different class.&#xD;
Intensification: Defined as any of the following: adding meal time insulin in basal insulin analog QD group; changing from BID to TID (Three times a day) in insulin analog mid mixture BID group&#xD;
Reduction in frequency: Defined as any of the following: changing from BID to QD; changing from TID to BID or QD.</description>
        <time_frame>Baseline through 48 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Insulin Treatment Change.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Insulin Treatment Change at Week 48</title>
          <description>Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency.&#xD;
Discontinuation: Defined as stopping insulin treatment for 30 days or more.&#xD;
Switch: Defined as stop the initial insulin therapy and started another insulin therapy of different class.&#xD;
Intensification: Defined as any of the following: adding meal time insulin in basal insulin analog QD group; changing from BID to TID (Three times a day) in insulin analog mid mixture BID group&#xD;
Reduction in frequency: Defined as any of the following: changing from BID to QD; changing from TID to BID or QD.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Insulin Treatment Change.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Discontinuation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Switching</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Intensification</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reduction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieve the HbA1c &lt;7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24</title>
        <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of &lt;7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.</description>
        <time_frame>24 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c &lt;7%.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieve the HbA1c &lt;7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24</title>
          <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of &lt;7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c &lt;7%.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="404"/>
                <count group_id="O2" value="410"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.1"/>
                    <measurement group_id="O2" value="29.0"/>
                  </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>0.2009</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.77</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieve the HbA1c &lt;7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48</title>
        <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of &lt;7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.</description>
        <time_frame>48 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c &lt;7%.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieve the HbA1c &lt;7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48</title>
          <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of &lt;7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c &lt;7%.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="404"/>
                <count group_id="O2" value="410"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.9"/>
                    <measurement group_id="O2" value="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8054</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.53</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score</title>
        <description>The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy. The SEITQ consists of 5 items (that is, statements). The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications. Each item score ranges from 1 (strongly disagree) to 7 (strongly agree). The total SEITQ score is the sum of each item scores, with the range of 5 to 35. Higher SEITQ score indicates better outcome (higher self-efficacy). LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect.</description>
        <time_frame>Baseline, 48 Weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for SEITQ Score.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Analog Mid Mixture</title>
            <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Basal Insulin Analog</title>
            <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score</title>
          <description>The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy. The SEITQ consists of 5 items (that is, statements). The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications. Each item score ranges from 1 (strongly disagree) to 7 (strongly agree). The total SEITQ score is the sum of each item scores, with the range of 5 to 35. Higher SEITQ score indicates better outcome (higher self-efficacy). LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for SEITQ Score.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="404"/>
                <count group_id="O2" value="410"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="0.23"/>
                    <measurement group_id="O2" value="-0.8" spread="0.24"/>
                  </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>0.7553</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.33</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 48 Weeks</time_frame>
      <desc>All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.</desc>
      <group_list>
        <group group_id="E1">
          <title>Insulin Analog Mid Mixture</title>
          <description>Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.</description>
        </group>
        <group group_id="E2">
          <title>Basal Insulin Analog</title>
          <description>Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="404"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglobulinaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Rheumatic heart disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Sudden hearing loss</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Vitreous haemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Gastrointestinal polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Intestinal polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia influenzal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Exposure during pregnancy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Clear cell renal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Colon neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Lung cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Oesophageal squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Parathyroid tumour benign</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Cerebrovascular insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Cervical radiculopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Peripheral nerve lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Vertebral artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiovascular somatic symptom disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Diabetic nephropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="223"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="233"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchiectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic vascular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 22.0</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="105" subjects_at_risk="404"/>
                <counts group_id="E2" subjects_affected="101" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Coronary artery insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hypertensive heart disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial septal defect</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Empty sella syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Thyroid disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Thyroid mass</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="404"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blindness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="404"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="404"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Eyelid thickening</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Macular oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Myopia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Refraction disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Retinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Retinal vascular occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Retinal vein occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Retinopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Retinopathy hypertensive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Bowel movement irregularity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Dysbiosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Gastric disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Gastric polyps</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Pancreatic cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </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="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="404"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Gallbladder polyp</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hepatic calcification</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hepatic cyst</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="404"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Endometritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Helicobacter infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hepatitis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="404"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Orchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Otitis externa fungal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Pelvic infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Pulpitis dental</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Rhinoscleroma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Syphilis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Tinea cruris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Tracheitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Trachoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="404"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="404"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bone fissure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Fractured sacrum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Ligament injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Scratch</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Tooth injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Bacterial test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Blood glucose decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Bone density decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Cardiothoracic ratio increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Computerised tomogram liver abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Computerised tomogram thorax abnormal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Diabetic ketosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="404"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hypoproteinaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Ketosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Overweight</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Vitamin b complex deficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </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="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Osteoarthropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Osteopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Spinal instability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Synovitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Haemangioma of liver</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid arteriosclerosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Carotid artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Cerebral arteriosclerosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Cerebral atrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Cerebrovascular disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Cerebrovascular stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="404"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Intellectual disability</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="404"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Dyssomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Diabetic nephropathy</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="404"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Glomerulonephritis chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Nephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="404"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Nephropathy</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="404"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Renal mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Atrophic vulvovaginitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Balanoposthitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="223"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="233"/>
              </event>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="223"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="233"/>
              </event>
              <event>
                <sub_title>Fallopian tube cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Menstruation irregular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Prostatic calcification</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="223"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="233"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="223"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="233"/>
              </event>
              <event>
                <sub_title>Uterine cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Pleural thickening</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Neurodermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Skin mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Angiopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Arterial occlusive disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="404"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Diabetic vascular disorder</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="404"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Peripheral coldness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="404"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Peripheral venous disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="410"/>
              </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>
      <email>ClinicalTrials.gov@lilly.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03018938
org study id: 16507
secondary id: F3Z-GH-IOQR
nct id: NCT03018938
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the effectiveness of basal insulin analog and insulin
      analog mid mixture in Chinese participants with type 2 diabetes mellitus.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
time frame: Baseline, 24 Weeks
description: HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.
measure: Change From Baseline to Week 48 in HbA1c
time frame: Baseline, 48 Weeks
description: HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Least Squares (LS) mean was determined by ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.
measure: Percentage of Participants Who Achieve HbA1c <7% at Week 24
time frame: 24 Weeks
description: Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
measure: Percentage of Participants Who Achieve HbA1c <7% at Week 48
time frame: 48 Weeks
description: Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
measure: Change From Baseline to Week 24 in Venous Fasting Plasma Glucose
time frame: Baseline, 24 Weeks
description: Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.
measure: Change From Baseline to Week 48 in Venous Fasting Plasma Glucose
time frame: Baseline, 48 Weeks
description: Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.
measure: Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
time frame: Baseline, 24 Weeks
description: Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.
measure: Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
time frame: Baseline, 48 Weeks
description: Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.
measure: Total Daily Insulin Dose at Week 24 and 48
time frame: 24 Weeks, 48 Weeks
description: Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.
measure: Change From Baseline to Week 24 in Body Weight
time frame: Baseline, 24 Weeks
description: LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.
measure: Change From Baseline to Week 48 in Body Weight
time frame: Baseline, 48 Weeks
description: LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.
measure: Rate of Hypoglycemia at Week 24 and 48
time frame: 24 Weeks, 48 Weeks
description: Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25) as an offset variable.
measure: Number of Participants With Insulin Treatment Change at Week 48
time frame: Baseline through 48 Weeks
description: Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency.
Discontinuation: Defined as stopping insulin treatment for 30 days or more.
Switch: Defined as stop the initial insulin therapy and started another insulin therapy of different class.
Intensification: Defined as any of the following: adding meal time insulin in basal insulin analog QD group; changing from BID to TID (Three times a day) in insulin analog mid mixture BID group
Reduction in frequency: Defined as any of the following: changing from BID to QD; changing from TID to BID or QD.
measure: Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24
time frame: 24 Weeks
description: Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.
measure: Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48
time frame: 48 Weeks
description: Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.
measure: Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score
time frame: Baseline, 48 Weeks
description: The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy. The SEITQ consists of 5 items (that is, statements). The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications. Each item score ranges from 1 (strongly disagree) to 7 (strongly agree). The total SEITQ score is the sum of each item scores, with the range of 5 to 35. Higher SEITQ score indicates better outcome (higher self-efficacy). LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect.
arm group label: Insulin Analog Mid Mixture
arm group type: Experimental
description: Insulin analog mid mixture given subcutaneously (SC).
arm group label: Basal Insulin Analog
arm group type: Experimental
description: Basal insulin analog given SC.
intervention type: Drug
intervention name: Insulin Analog Mid Mixture
description: Administered SC
arm group label: Insulin Analog Mid Mixture
intervention type: Drug
intervention name: Basal Insulin Analog
description: Administered SC
arm group label: Basal Insulin Analog
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin
mesh term: Insulin, Globin Zinc
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/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 