<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/NCT04405076</url>
  </required_header>
  <id_info>
    <org_study_id>mRNA-1273-P201</org_study_id>
    <secondary_id>75A50120C00034</secondary_id>
    <nct_id>NCT04405076</nct_id>
  </id_info>
  <brief_title>Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older</brief_title>
  <official_title>A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ModernaTX, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biomedical Advanced Research and Development Authority</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>ModernaTX, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose&#xD;
      levels of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-COV-2) vaccine in&#xD;
      adults 18 years of age or older.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 3-part Phase 2a study, with Part A (Blinded Phase), Part B (Open-label&#xD;
      Interventional Phase), and Part C (Rollover Proof of Concept).&#xD;
&#xD;
      Participants in Part A are blinded to their treatment assignment, with participants receiving&#xD;
      either 2 active mRNA-1273 vaccine doses or placebo. Part B of the study is designed to offer&#xD;
      participants to be unblinded so that participants who received placebo in Part A can request&#xD;
      2 doses of open-label mRNA-1273 vaccine. Additionally, participants who originally received 1&#xD;
      or 2 doses of mRNA-1273 (50 microgram [μg] or 100 μg vaccine) during Part A, will have the&#xD;
      opportunity to request to receive a single booster dose of mRNA-1273.&#xD;
&#xD;
      Part C will be a proof-of-concept rollover study to evaluate a vaccine to treat mutations of&#xD;
      SARS-CoV2, such as the S-protein of the B.1.351 variant. Part C will include approximately 60&#xD;
      participants, who are currently enrolled in Moderna's Phase 3 mRNA-1273-P301 study&#xD;
      (NCT04470427), have already been unblinded, and have previously received 2 doses of mRNA-1273&#xD;
      at least 6 months earlier. At enrollment into Part C of this study, their participation in&#xD;
      mRNA-1273-P301 study will be terminated. Part C will evaluate the safety and immunogenicity&#xD;
      of 2 dose levels (20 µg and 50 µg) of mRNA-1273.351 and mRNA-1273/mRNA-1273.351 mixture (50&#xD;
      µg total), given as a single booster dose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Actual">October 28, 2021</completion_date>
  <primary_completion_date type="Actual">October 28, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Part A is observer-blind. During Part B participants may request to be unblinded by scheduling a Participant Decision clinic visit. Part C is open-label.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)</measure>
    <time_frame>7 days post-vaccination</time_frame>
    <description>Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs (&quot;Other&quot;), regardless of causality, is located in the Reported &quot;Adverse Events&quot; section.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Unsolicited AEs</measure>
    <time_frame>Up to 28 days post-vaccination</time_frame>
    <description>An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs (&quot;Other&quot;) reported up to the end of the study (up to Month 15), regardless of causality, is located in the Reported &quot;Adverse Events&quot; section.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Medically-Attended Adverse Events (MAAEs)</measure>
    <time_frame>Up to Month 15</time_frame>
    <description>An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). A summary of SAEs and all nonserious AEs (&quot;Other&quot;), regardless of causality, is located in the Reported &quot;Adverse Events&quot; section.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With SAEs</measure>
    <time_frame>Up to Month 15</time_frame>
    <description>An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs (&quot;Other&quot;), regardless of causality, is located in the Reported &quot;Adverse Events&quot; section.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)</measure>
    <time_frame>Days 1 (Baseline), 29, 43, 57, and 209</time_frame>
    <description>The geometric mean (GM) level of VAC58 spike immunoglobulin G (IgG) antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ if actual values were not available. LLOQ was 1 and ULOQ was 2052. The 95% confidence intervals (CIs) were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part B: Level of SARS-CoV-2-Specific bAb as Measured by ELISA</measure>
    <time_frame>Days 1 (Baseline) and 29</time_frame>
    <description>The GM level of VAC65 spike IgG antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 1 and ULOQ was 2052. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part C: Level of SARS-CoV-2-Specific bAb as Measured by MSD</measure>
    <time_frame>Days 1 (Baseline), 8, 15, and 29</time_frame>
    <description>The GM level of SARS-CoV-2 protein antibody against B.1.351, as measured by MSD MULTIPLEX is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 18 and ULOQ was 4200000. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)</measure>
    <time_frame>Days 1 (Baseline), 29, 43, 57, and 209</time_frame>
    <description>The GM titer (microneutralization [MN] and MN50) of serum nAb against SARS-CoV-2 as measured by live virus MN assays is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. For MN, LLOQ was 40 and ULOQ was 1280 at Days 1 (Baseline), 29, 43, and 57. For MN50, LLOQ was 91.10 and ULOQ was 2031.87 at Days 1 (Baseline), 29, 43, and 57. For MN, LLOQ was 160 and ULOQ was 1280 at Day 209. For MN50, LLOQ was 318.46 and ULOQ was 1917.83 at Day 209. The 95% CI was calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM titer, then back transformed to the original scale for presentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Titer of SARS-CoV-2-Specific nAb</measure>
    <time_frame>Days 1 (Baseline), 29, and 181</time_frame>
    <description>The GM titer (50% inhibitory dose [ID50], 80% inhibitory dose [ID80]) of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 18.5 and ULOQ was 45118 for IC50. LLOQ was 14.3 and ULOQ was 10232 for ID80. The 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Titer of SARS-CoV-2-Specific nAb</measure>
    <time_frame>Days 1 (Baseline), 8, 15, 29, and 181</time_frame>
    <description>The GM titer (ID50, ID80) of nAb against SARS-CoV-2 pseudotyped viruses (original strain and beta variant [B.1.351]) as measured by pseudovirus nAb assay is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. For NAb ID50 Titers, LLOQ was 18.5 and ULOQ was 45118. For NAb ID80 Titers, LLOQ was 14.3 and ULOQ was 10232. For NAb ID50 Titers against B.1.351, LLOQ was 19.5 and ULOQ was 385.7. For NAb ID80 Titers against B.1.351, LLOQ was 12.5 and ULOQ was 102.2. The 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Percentage of Participants With Seroconversion From Baseline</measure>
    <time_frame>Days 29, 43, and 57</time_frame>
    <description>Based on MN titers and MN50 titers of serum nAb against SARS-CoV-2 as measured by live virus MN assays, percentage of participants with seroconversion from baseline are reported with 2-sided 95% CI using the Clopper-Pearson method at each post-baseline timepoint. Seroconversion at a participant level was defined as a change of nAb titer from below the limit of detection (LOD) or LLOQ to equal to or above LOD or LLOQ (respectively), or a 4-times or higher titer ratio in participants with pre-existing nAb titers. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. For MN, LLOQ was 40 and ULOQ was 1280. For MN50, LLOQ was 91.10 and ULOQ was 2031.87.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Percentage of Participants With Seroconversion From Baseline</measure>
    <time_frame>Days 29 and 181</time_frame>
    <description>Based on ID50 and ID80 titers of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay, % of participants with seroconversion from baseline reported with 2-sided 95% CI using Clopper-Pearson method at each postbaseline timepoint. Seroconversion at participant level defined as change of nAb titer from below LOD or LLOQ to equal to or above LOD or LLOQ (respectively) or 4-times or higher titer ratio in participants with preexisting nAb titers. Antibody values &lt;LLOQ replaced by 0.5*LLOQ. Values &gt;ULOQ converted to ULOQ. LLOQ: 18.5 and ULOQ: 45118 for IC50. LLOQ: 14.3 and ULOQ: 10232 for ID80. 95% CI calculated based on t-distribution of log-transformed values for GMT, then back transformed to original scale for presentation. PP Set: participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Percentage of Participants With Seroconversion From Baseline</measure>
    <time_frame>Days 8, 15, 29, and 181</time_frame>
    <description>Based on ID50 titers and ID80 titers of nAb against SARS-CoV-2 pseudotyped viruses (original strain and beta variant [B.1.351]) as measured by pseudovirus nAb assay, percentage of participants with seroconversion from baseline are reported with 2-sided 95% CI using Clopper-Pearson method at each post-baseline timepoint. Seroconversion at participant level defined as a change of nAb titer from below LOD or LLOQ ≥LOD or LLOQ (respectively), or a 4-times or higher titer ratio in participants with pre-existing nAb titers. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values &gt;ULOQ were converted to ULOQ. NAb ID50 Titers: LLOQ was 18.5 and ULOQ was 45118. NAb ID80 Titers: LLOQ was 14.3 and ULOQ was 10232. NAb ID50 Titers against B.1.351: LLOQ was 19.5 and ULOQ was 385.7. NAb ID80 Titers against B.1.351: LLOQ was 12.5 and ULOQ was 102.2. 95% CI calculated based on t-distribution of log-transformed values for GMT, then back transformed to original scale for presentation.</description>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">660</enrollment>
  <condition>SARS-CoV-2</condition>
  <arm_group>
    <arm_group_label>mRNA-1273: Dose 50 microgram (ug) - Participants Aged 18-54 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A: Participants aged 18-54 years will receive 1 intramuscular (IM) injection of 50 ug mRNA-1273 on Day 1 and on Day 29.&#xD;
Part B: Participants aged 18-54 years who choose to be unblinded and received 50 ug mRNA-1273 during Part A, will receive 1 IM injection of mRNA-1273 (booster dose) on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mRNA-1273: Dose 50 ug - Participants Aged 55+ years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A: Participants aged 55+ years will receive 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.&#xD;
Part B: Participants aged 55+ years who choose to be unblinded and received 50 ug mRNA-1273 during Part A, will receive 1 IM injection of mRNA-1273 (booster dose) on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mRNA-1273: Dose 100 ug - Participants Aged 18-54 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A: Participants aged 18-54 years will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.&#xD;
Part B: Participants aged 18-54 years who choose to be unblinded and received 100 ug mRNA-1273 during Part A, will receive 1 IM injection of mRNA-1273 (booster dose) on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mRNA-1273: Dose 100 ug - Participants Aged 55+ years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A: Participants aged 55+ years will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.&#xD;
Part B: Participants aged 55+ years who choose to be unblinded and received 100 ug mRNA-1273 during Part A, will receive 1 IM injection of mRNA-1273 (booster dose) on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Part A) and mRNA-1273 100 ug (Part B) - Participants Aged 18-54 years</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Part A: Participants aged 18-54 years will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.&#xD;
Part B: Participants aged 18-54 who choose to be unblinded and received mRNA-1273-matching placebo during Part A, will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and Day 29.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Part A) and mRNA-1273 100 ug (Part B) - Participants Aged 55+ years</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Part A: Participants aged 55+ years will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.&#xD;
Part B: Participants aged 55+ years who choose to be unblinded and received mRNA-1273-matching placebo during Part A, will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and Day 29.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mRNA 1273.351 20 ug (Part C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part C: Participants will receive 1 IM booster dose of 20 ug of mRNA 1273.351 on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mRNA 1273.351 50 ug (Part C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part C: Participants will receive 1 IM booster dose of 50 ug of mRNA 1273.351 on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mRNA-1273/mRNA-1273.351 mixture (Part C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part C: Participants will receive 1 IM booster dose of 50 ug of mRNA-1273/mRNA-1273.351 mixture on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Biological: mRNA-1273</intervention_name>
    <description>Sterile liquid for injection</description>
    <arm_group_label>Placebo (Part A) and mRNA-1273 100 ug (Part B) - Participants Aged 18-54 years</arm_group_label>
    <arm_group_label>Placebo (Part A) and mRNA-1273 100 ug (Part B) - Participants Aged 55+ years</arm_group_label>
    <arm_group_label>mRNA-1273/mRNA-1273.351 mixture (Part C)</arm_group_label>
    <arm_group_label>mRNA-1273: Dose 100 ug - Participants Aged 18-54 years</arm_group_label>
    <arm_group_label>mRNA-1273: Dose 100 ug - Participants Aged 55+ years</arm_group_label>
    <arm_group_label>mRNA-1273: Dose 50 microgram (ug) - Participants Aged 18-54 years</arm_group_label>
    <arm_group_label>mRNA-1273: Dose 50 ug - Participants Aged 55+ years</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>0.9% sodium chloride (normal saline) injection</description>
    <arm_group_label>Placebo (Part A) and mRNA-1273 100 ug (Part B) - Participants Aged 18-54 years</arm_group_label>
    <arm_group_label>Placebo (Part A) and mRNA-1273 100 ug (Part B) - Participants Aged 55+ years</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>mRNA-1273.351</intervention_name>
    <description>Sterile liquid for injection</description>
    <arm_group_label>mRNA 1273.351 20 ug (Part C)</arm_group_label>
    <arm_group_label>mRNA 1273.351 50 ug (Part C)</arm_group_label>
    <arm_group_label>mRNA-1273/mRNA-1273.351 mixture (Part C)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
        Each participant must meet all of the following criteria during the screening period and at&#xD;
        Day 1, unless noted otherwise, to be enrolled in this study:&#xD;
&#xD;
          1. Male or female, 18 years of age or older at the time of consent (Screening Visit, Day&#xD;
             0). For Part B, participants must have been previously enrolled in the mRNA-1273 P201&#xD;
             study.&#xD;
&#xD;
          2. Understands and agrees to comply with the study procedures and provides written&#xD;
             informed consent.&#xD;
&#xD;
          3. According to the assessment of the investigator, is in good general health and can&#xD;
             comply with study procedures.&#xD;
&#xD;
          4. Female participants of nonchildbearing potential may be enrolled in the study.&#xD;
             Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal&#xD;
             ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as&#xD;
             amenorrhea for ≥12 consecutive months prior to Screening (Day 0) without an&#xD;
             alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured&#xD;
             at the discretion of the investigator to confirm postmenopausal status.&#xD;
&#xD;
          5. Female participants of childbearing potential may be enrolled in the study if the&#xD;
             participant fulfills all the following criteria:&#xD;
&#xD;
               -  Has a negative pregnancy test at Screening (Day 0) and on the day of the first&#xD;
                  injection (Day 1).&#xD;
&#xD;
               -  Has practiced adequate contraception or has abstained from all activities that&#xD;
                  could result in pregnancy for at least 28 days prior to the first injection (Day&#xD;
                  1).&#xD;
&#xD;
               -  Has agreed to continue adequate contraception through 3 months following the&#xD;
                  second injection (Day 29).&#xD;
&#xD;
               -  Is not currently breastfeeding.&#xD;
&#xD;
             Adequate female contraception is defined as consistent and correct use of a Food and&#xD;
             Drug Administration (FDA) approved contraceptive method in accordance with the product&#xD;
             label. For example:&#xD;
&#xD;
               -  Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction&#xD;
                  with spermicide&#xD;
&#xD;
               -  Intrauterine device&#xD;
&#xD;
               -  Prescription hormonal contraceptive taken or administered via oral (pill),&#xD;
                  transdermal (patch), subdermal, or IM route&#xD;
&#xD;
               -  Sterilization of a female participant's monogamous male partner prior to entry&#xD;
                  into the study Note: periodic abstinence (for example, calendar, ovulation,&#xD;
                  symptothermal, post-ovulation methods) and withdrawal are not acceptable methods&#xD;
                  of contraception.&#xD;
&#xD;
          6. Male participants engaging in activity that could result in pregnancy of sexual&#xD;
             partners must agree to practice adequate contraception from the time of the first&#xD;
             injection and through 3 months after the last injection.&#xD;
&#xD;
        Adequate contraception for male participants is defined as:&#xD;
&#xD;
          -  Monogamous relationship with a female partner using an intrauterine device or hormonal&#xD;
             contraception (described above)&#xD;
&#xD;
          -  Use of barrier methods and spermicide&#xD;
&#xD;
          -  History of surgical sterilization&#xD;
&#xD;
          -  Male participants with partners who have become pregnant prior to Screening are&#xD;
             eligible to participate in the study.&#xD;
&#xD;
        Additional Key Inclusion Criteria for Part C&#xD;
&#xD;
        1. Participants must have been previously enrolled in the mRNA-1273-P301 study and must&#xD;
        have received 2 doses of mRNA-1273 in Part A, has been unblinded and aware of their actual&#xD;
        treatment in Study mRNA-1273-P301, must have been compliant in Study mRNA-1273-P301 (was&#xD;
        not withdrawn or discontinued early), and has been at least 6 months since their second&#xD;
        dose in Study mRNA-1273-P301 prior to enrollment in this part.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
        Participants meeting any of the following criteria at the Screening Visit (Day 0) or at Day&#xD;
        1, unless noted otherwise, will be excluded from the study:&#xD;
&#xD;
          1. Pregnant or breastfeeding.&#xD;
&#xD;
          2. Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever&#xD;
             is defined as a body temperature ≥38.0°Celsius/100.4°Fahrenheit. Participants meeting&#xD;
             this criterion may be rescheduled within the relevant window periods. Afebrile&#xD;
             participants with minor illnesses can be enrolled at the discretion of the&#xD;
             investigator.&#xD;
&#xD;
          3. Current treatment with investigational agents for prophylaxis against COVID-19.&#xD;
&#xD;
          4. Has a medical, psychiatric, or occupational condition that may pose additional risk as&#xD;
             a result of participation, or that could interfere with safety assessments or&#xD;
             interpretation of results according to the investigator's judgment.&#xD;
&#xD;
          5. Is a healthcare worker or a member of an emergency response team.&#xD;
&#xD;
          6. Current use of any inhaled substance (for example, tobacco or cannabis smoke, nicotine&#xD;
             vapors).&#xD;
&#xD;
          7. History of chronic smoking (≥1 cigarette a day) within 1 year of the Screening Visit&#xD;
             (Day 0).&#xD;
&#xD;
          8. History of illegal substance use or alcohol abuse within the past 2 years. This&#xD;
             exclusion does not apply to historical cannabis use that was formerly illegal in the&#xD;
             participant's state but is legal at the time of Screening.&#xD;
&#xD;
          9. Known history of hypertension, or systolic blood pressure &gt;150 millimeter of mercury&#xD;
             (mmHg) in participants in Cohort 1 (≥18 to &lt;55 years old) or systolic blood pressure&#xD;
             &gt;160 mmHg in participants in Cohort 2 (≥55 years old) at the Screening Visit (Day 0).&#xD;
&#xD;
         10. Known history of hypotension or systolic blood pressure &lt;85 mmHg at the Screening&#xD;
             Visit (Day 0).&#xD;
&#xD;
         11. Diabetes mellitus&#xD;
&#xD;
         12. Diagnosis of chronic pulmonary disease (for example, chronic obstructive pulmonary&#xD;
             disease, asthma)&#xD;
&#xD;
         13. Chronic cardiovascular disease&#xD;
&#xD;
         14. Resides in a nursing home&#xD;
&#xD;
         15. Grade 1 or higher toxicity on clinical safety laboratory testing at the Screening&#xD;
             Visit (Day 0)&#xD;
&#xD;
         16. Current or previous diagnosis of immunocompromising condition, immune-mediated&#xD;
             disease, or other immunosuppressive condition.&#xD;
&#xD;
         17. Received systemic immunosuppressants or immune-modifying drugs for &gt;14 days in total&#xD;
             within 6 months prior to the Screening Visit (Day 0) (for corticosteroids ≥20&#xD;
             milligrams (mg)/day of prednisone equivalent). Topical tacrolimus is allowed if not&#xD;
             used within 14 days prior to the Screening Visit (Day 0).&#xD;
&#xD;
         18. Anticipating the need for immunosuppressive treatment at any time during participation&#xD;
             in the study.&#xD;
&#xD;
         19. Positive serology for hepatitis B virus surface antigen, hepatitis C virus antibody,&#xD;
             or human immunodeficiency virus (HIV) type 1 or 2 antibodies identified at the&#xD;
             Screening Visit (Day 0).&#xD;
&#xD;
         20. History of anaphylaxis, urticaria, or other significant AR requiring medical&#xD;
             intervention after receipt of a vaccine.&#xD;
&#xD;
         21. Bleeding disorder considered a contraindication to IM injection or phlebotomy.&#xD;
&#xD;
         22. Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer).&#xD;
&#xD;
         23. Has received or plans to receive a licensed vaccine ≤28 days prior to the first&#xD;
             injection (Day 1) or plans to receive a licensed vaccine within 28 days before or&#xD;
             after any study injection. Licensed influenza vaccines may be received more than 14&#xD;
             days before or after any study injection.&#xD;
&#xD;
         24. Receipt of systemic immunoglobulins or blood products within 3 months prior to the&#xD;
             Screening Visit (Day 0) or plans for receipt during the study.&#xD;
&#xD;
         25. Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit (Day&#xD;
             0) or plans to donate blood products during the study.&#xD;
&#xD;
         26. Participated in an interventional clinical study (other than mRNA-1273 P301) within 28&#xD;
             days prior to the Screening Visit (Day 0) or plans to do so while participating in&#xD;
             this study.&#xD;
&#xD;
         27. Is an immediate family member or household member of study personnel&#xD;
&#xD;
        Additional Key Exclusion Criteria for Part C&#xD;
&#xD;
          1. Is SARS-CoV-2 positive by Reverse transcription polymerase chain reaction (RT-PCR)&#xD;
             (central or local testing) at baseline or at any time during the mRNA-1273-P301 study&#xD;
             regardless of the presence or absence of symptoms consistent with COVID-19.&#xD;
&#xD;
          2. Had any SAE in the mRNA-1273-P301 study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Multispecialty Research</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Multispecialty Research</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Norfolk</city>
        <state>Nebraska</state>
        <zip>68701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trial Management Associates</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Dakota Dunes</city>
        <state>South Dakota</state>
        <zip>57049</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research</name>
      <address>
        <city>San Angelo</city>
        <state>Texas</state>
        <zip>76904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <results_first_submitted>October 21, 2022</results_first_submitted>
  <results_first_submitted_qc>December 6, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 30, 2022</results_first_posted>
  <last_update_submitted>December 6, 2022</last_update_submitted>
  <last_update_submitted_qc>December 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mRNA-1273</keyword>
  <keyword>mRNA-1273 vaccine</keyword>
  <keyword>mRNA-1273.351</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>SARS-CoV-2 Vaccine</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>Virus Diseases</keyword>
  <keyword>Messenger RNA</keyword>
  <keyword>COVID 19</keyword>
  <keyword>COVID 19 Vaccine</keyword>
  <keyword>Moderna</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>April 28, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT04405076/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>November 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT04405076/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 9, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT04405076/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants in Part A were blinded to study treatment. After completion of Part A, participants could have chosen to be unblinded and to participate in Part B (open-label). Participants in Part C (proof-of-concept rollover) were unblinded and had received 2 doses of mRNA-1273 in Study mRNA-1273-P301 (Study P301; NCT04470427).</recruitment_details>
      <pre_assignment_details>Part A participants received 50 microgram (µg) mRNA-1273, 100 µg mRNA-1273, or placebo (N=600). Participants who received placebo in Part A, received 100 ug mRNA-1273 in Part B (N=158). Participants who received 50 or 100 ug mRNA-1273 in Part A, received 50 ug mRNA-1273 in Part B (N=344). Participants in Part C (N=60) received a booster dose of 20 or 50 µg of mRNA-1273.351 or 50 µg mRNA-1273/mRNA-1273.351 mixture. Total number of enrolled participants for the study=660.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part A: 50 ug mRNA-1273</title>
          <description>Participants received 1 intramuscular (IM) injection of 50 ug mRNA-1273 on Day 1 and on Day 29.</description>
        </group>
        <group group_id="P2">
          <title>Part A: 100 ug mRNA-1273</title>
          <description>Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.</description>
        </group>
        <group group_id="P3">
          <title>Part A: Placebo</title>
          <description>Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.</description>
        </group>
        <group group_id="P4">
          <title>Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273</title>
          <description>Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
        </group>
        <group group_id="P5">
          <title>Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273</title>
          <description>Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
        </group>
        <group group_id="P6">
          <title>Part B: Placebo Then 100 ug mRNA-1273</title>
          <description>Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.</description>
        </group>
        <group group_id="P7">
          <title>Part C: 20 ug mRNA-1273.351</title>
          <description>Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.</description>
        </group>
        <group group_id="P8">
          <title>Part C: 50 ug mRNA-1273.351</title>
          <description>Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.</description>
        </group>
        <group group_id="P9">
          <title>Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture</title>
          <description>Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part A (Blinded Phase)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
                <participants group_id="P2" count="200"/>
                <participants group_id="P3" count="200"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug During Part A</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
                <participants group_id="P2" count="200"/>
                <participants group_id="P3" count="200"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="188"/>
                <participants group_id="P2" count="185"/>
                <participants group_id="P3" count="182"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="18"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal of consent (COVID-19 non-infection related)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal of consent (other)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than Specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part B (Open-Label Interventional Phase)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="173"/>
                <participants group_id="P5" count="171"/>
                <participants group_id="P6" count="158"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug During Part B</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="173"/>
                <participants group_id="P5" count="171"/>
                <participants group_id="P6" count="158"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="161"/>
                <participants group_id="P5" count="166"/>
                <participants group_id="P6" count="152"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="12"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part C (Rollover Proof of Concept)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="20"/>
                <participants group_id="P8" count="20"/>
                <participants group_id="P9" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="18"/>
                <participants group_id="P8" count="18"/>
                <participants group_id="P9" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal of consent (other)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Set: All participants who received any study injection in their respective part of the study. Note, participants who received placebo in Part A, received 100 ug mRNA-1273 in Part B (N=158). Participants who received 50 or 100 ug mRNA-1273 in Part A, received 50 ug mRNA-1273 in Part B (N=344). Since Baseline Characteristics data for participants in Part B are included in Part A, separate columns are not reported here for Part B.</population>
      <group_list>
        <group group_id="B1">
          <title>Part A: 50 ug mRNA-1273</title>
          <description>Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.</description>
        </group>
        <group group_id="B2">
          <title>Part A: 100 ug mRNA-1273</title>
          <description>Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.</description>
        </group>
        <group group_id="B3">
          <title>Part A: Placebo</title>
          <description>Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.</description>
        </group>
        <group group_id="B4">
          <title>Part C: 20 ug mRNA-1273.351</title>
          <description>Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.</description>
        </group>
        <group group_id="B5">
          <title>Part C: 50 ug mRNA-1273.351</title>
          <description>Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.</description>
        </group>
        <group group_id="B6">
          <title>Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture</title>
          <description>Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.</description>
        </group>
        <group group_id="B7">
          <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="200"/>
            <count group_id="B2" value="200"/>
            <count group_id="B3" value="200"/>
            <count group_id="B4" value="20"/>
            <count group_id="B5" value="20"/>
            <count group_id="B6" value="20"/>
            <count group_id="B7" value="660"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Between 18 and 55 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="100"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="331"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=55 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="100"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="11"/>
                    <measurement group_id="B7" value="329"/>
                  </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="137"/>
                    <measurement group_id="B2" value="124"/>
                    <measurement group_id="B3" value="129"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="422"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="71"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="12"/>
                    <measurement group_id="B7" value="238"/>
                  </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="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="184"/>
                    <measurement group_id="B2" value="184"/>
                    <measurement group_id="B3" value="184"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="20"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="610"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="188"/>
                    <measurement group_id="B2" value="188"/>
                    <measurement group_id="B3" value="193"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="19"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="627"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiracial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)</title>
        <description>Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs (&quot;Other&quot;), regardless of causality, is located in the Reported &quot;Adverse Events&quot; section.</description>
        <time_frame>7 days post-vaccination</time_frame>
        <population>Solicited Safety Set for Parts A, B, and C included all participants who received any study injection in the applicable part of the study and contributed any solicited AR data (that is, had at least 1 post-baseline solicited safety assessment in the applicable part of the study). Number Analyzed = participants who were evaluable at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: 50 ug mRNA-1273</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Part A: 100 ug mRNA-1273</title>
            <description>Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Placebo</title>
            <description>Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
          </group>
          <group group_id="O5">
            <title>Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
          </group>
          <group group_id="O6">
            <title>Part B: Placebo Then 100 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.</description>
          </group>
          <group group_id="O7">
            <title>Part C: 20 ug mRNA-1273.351</title>
            <description>Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part C: 50 ug mRNA-1273.351</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.</description>
          </group>
          <group group_id="O9">
            <title>Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)</title>
          <description>Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs (&quot;Other&quot;), regardless of causality, is located in the Reported &quot;Adverse Events&quot; section.</description>
          <population>Solicited Safety Set for Parts A, B, and C included all participants who received any study injection in the applicable part of the study and contributed any solicited AR data (that is, had at least 1 post-baseline solicited safety assessment in the applicable part of the study). Number Analyzed = participants who were evaluable at specified timepoints.</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="200"/>
                <count group_id="O2" value="200"/>
                <count group_id="O3" value="200"/>
                <count group_id="O4" value="164"/>
                <count group_id="O5" value="167"/>
                <count group_id="O6" value="157"/>
                <count group_id="O7" value="19"/>
                <count group_id="O8" value="19"/>
                <count group_id="O9" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="69"/>
                    <measurement group_id="O3" value="72"/>
                    <measurement group_id="O4" value="65"/>
                    <measurement group_id="O5" value="73"/>
                    <measurement group_id="O6" value="50"/>
                    <measurement group_id="O7" value="13"/>
                    <measurement group_id="O8" value="10"/>
                    <measurement group_id="O9" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="90"/>
                    <measurement group_id="O3" value="21"/>
                    <measurement group_id="O4" value="59"/>
                    <measurement group_id="O5" value="59"/>
                    <measurement group_id="O6" value="71"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="29"/>
                    <measurement group_id="O5" value="18"/>
                    <measurement group_id="O6" value="28"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Unsolicited AEs</title>
        <description>An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs (&quot;Other&quot;) reported up to the end of the study (up to Month 15), regardless of causality, is located in the Reported &quot;Adverse Events&quot; section.</description>
        <time_frame>Up to 28 days post-vaccination</time_frame>
        <population>Safety Set: All participants who received any study injection in their respective part of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: 50 ug mRNA-1273</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Part A: 100 ug mRNA-1273</title>
            <description>Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Placebo</title>
            <description>Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
          </group>
          <group group_id="O5">
            <title>Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
          </group>
          <group group_id="O6">
            <title>Part B: Placebo Then 100 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.</description>
          </group>
          <group group_id="O7">
            <title>Part C: 20 ug mRNA-1273.351</title>
            <description>Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part C: 50 ug mRNA-1273.351</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.</description>
          </group>
          <group group_id="O9">
            <title>Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unsolicited AEs</title>
          <description>An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs (&quot;Other&quot;) reported up to the end of the study (up to Month 15), regardless of causality, is located in the Reported &quot;Adverse Events&quot; section.</description>
          <population>Safety Set: All participants who received any study injection in their respective part of the study.</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="200"/>
                <count group_id="O2" value="200"/>
                <count group_id="O3" value="200"/>
                <count group_id="O4" value="173"/>
                <count group_id="O5" value="171"/>
                <count group_id="O6" value="158"/>
                <count group_id="O7" value="20"/>
                <count group_id="O8" value="20"/>
                <count group_id="O9" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="51"/>
                    <measurement group_id="O4" value="17"/>
                    <measurement group_id="O5" value="25"/>
                    <measurement group_id="O6" value="42"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Medically-Attended Adverse Events (MAAEs)</title>
        <description>An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). A summary of SAEs and all nonserious AEs (&quot;Other&quot;), regardless of causality, is located in the Reported &quot;Adverse Events&quot; section.</description>
        <time_frame>Up to Month 15</time_frame>
        <population>Safety Set: All participants who received any study injection in their respective part of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: 50 ug mRNA-1273</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Part A: 100 ug mRNA-1273</title>
            <description>Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Placebo</title>
            <description>Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
          </group>
          <group group_id="O5">
            <title>Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
          </group>
          <group group_id="O6">
            <title>Part B: Placebo Then 100 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.</description>
          </group>
          <group group_id="O7">
            <title>Part C: 20 ug mRNA-1273.351</title>
            <description>Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part C: 50 ug mRNA-1273.351</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.</description>
          </group>
          <group group_id="O9">
            <title>Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Medically-Attended Adverse Events (MAAEs)</title>
          <description>An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). A summary of SAEs and all nonserious AEs (&quot;Other&quot;), regardless of causality, is located in the Reported &quot;Adverse Events&quot; section.</description>
          <population>Safety Set: All participants who received any study injection in their respective part of the study.</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="200"/>
                <count group_id="O2" value="200"/>
                <count group_id="O3" value="200"/>
                <count group_id="O4" value="173"/>
                <count group_id="O5" value="171"/>
                <count group_id="O6" value="158"/>
                <count group_id="O7" value="20"/>
                <count group_id="O8" value="20"/>
                <count group_id="O9" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="64"/>
                    <measurement group_id="O4" value="42"/>
                    <measurement group_id="O5" value="47"/>
                    <measurement group_id="O6" value="59"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With SAEs</title>
        <description>An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs (&quot;Other&quot;), regardless of causality, is located in the Reported &quot;Adverse Events&quot; section.</description>
        <time_frame>Up to Month 15</time_frame>
        <population>Safety Set: All participants who received any study injection in their respective part of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: 50 ug mRNA-1273</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Part A: 100 ug mRNA-1273</title>
            <description>Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Placebo</title>
            <description>Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O4">
            <title>Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
          </group>
          <group group_id="O5">
            <title>Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
          </group>
          <group group_id="O6">
            <title>Part B: Placebo Then 100 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.</description>
          </group>
          <group group_id="O7">
            <title>Part C: 20 ug mRNA-1273.351</title>
            <description>Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part C: 50 ug mRNA-1273.351</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.</description>
          </group>
          <group group_id="O9">
            <title>Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With SAEs</title>
          <description>An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs (&quot;Other&quot;), regardless of causality, is located in the Reported &quot;Adverse Events&quot; section.</description>
          <population>Safety Set: All participants who received any study injection in their respective part of the study.</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="200"/>
                <count group_id="O2" value="200"/>
                <count group_id="O3" value="200"/>
                <count group_id="O4" value="173"/>
                <count group_id="O5" value="171"/>
                <count group_id="O6" value="158"/>
                <count group_id="O7" value="20"/>
                <count group_id="O8" value="20"/>
                <count group_id="O9" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)</title>
        <description>The geometric mean (GM) level of VAC58 spike immunoglobulin G (IgG) antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ if actual values were not available. LLOQ was 1 and ULOQ was 2052. The 95% confidence intervals (CIs) were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.</description>
        <time_frame>Days 1 (Baseline), 29, 43, 57, and 209</time_frame>
        <population>Per-Protocol (PP) Set included randomized participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants evaluable at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: 50 ug mRNA-1273</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Part A: 100 ug mRNA-1273</title>
            <description>Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Placebo</title>
            <description>Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)</title>
          <description>The geometric mean (GM) level of VAC58 spike immunoglobulin G (IgG) antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ if actual values were not available. LLOQ was 1 and ULOQ was 2052. The 95% confidence intervals (CIs) were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.</description>
          <population>Per-Protocol (PP) Set included randomized participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants evaluable at specified timepoints.</population>
          <units>arbitrary units per mL (AU/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="189"/>
                <count group_id="O3" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                    <count group_id="O2" value="189"/>
                    <count group_id="O3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70" lower_limit="0.63" upper_limit="0.78"/>
                    <measurement group_id="O2" value="0.67" lower_limit="0.60" upper_limit="0.73"/>
                    <measurement group_id="O3" value="0.67" lower_limit="0.61" upper_limit="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="183"/>
                    <count group_id="O2" value="189"/>
                    <count group_id="O3" value="182"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.42" lower_limit="52.05" upper_limit="67.82"/>
                    <measurement group_id="O2" value="81.51" lower_limit="70.19" upper_limit="94.67"/>
                    <measurement group_id="O3" value="0.68" lower_limit="0.61" upper_limit="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="180"/>
                    <count group_id="O3" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="720.85" lower_limit="660.30" upper_limit="786.96"/>
                    <measurement group_id="O2" value="834.66" lower_limit="765.28" upper_limit="910.33"/>
                    <measurement group_id="O3" value="0.65" lower_limit="0.59" upper_limit="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="519.48" lower_limit="474.00" upper_limit="569.33"/>
                    <measurement group_id="O2" value="647.22" lower_limit="588.98" upper_limit="711.21"/>
                    <measurement group_id="O3" value="0.67" lower_limit="0.60" upper_limit="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 209</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.02" lower_limit="87.58" upper_limit="107.47"/>
                    <measurement group_id="O2" value="128.00" lower_limit="114.44" upper_limit="143.18"/>
                    <measurement group_id="O3" value="0.91" lower_limit="0.73" upper_limit="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part B: Level of SARS-CoV-2-Specific bAb as Measured by ELISA</title>
        <description>The GM level of VAC65 spike IgG antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 1 and ULOQ was 2052. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.</description>
        <time_frame>Days 1 (Baseline) and 29</time_frame>
        <population>PP Set. Number Analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the &quot;Part B: Placebo then 100 ug mRNA&quot; arm were not tested and no data were generated as results were not thought to provide additional information. After Part B samples were obtained, it was determined that the extensive results for immunogenicity profiles of 2 doses of 100 ug mRNA-1273 that were obtained during Part A of this study and in Study P301 demonstrated enough immune response data.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
          </group>
          <group group_id="O2">
            <title>Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Level of SARS-CoV-2-Specific bAb as Measured by ELISA</title>
          <description>The GM level of VAC65 spike IgG antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 1 and ULOQ was 2052. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.</description>
          <population>PP Set. Number Analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the &quot;Part B: Placebo then 100 ug mRNA&quot; arm were not tested and no data were generated as results were not thought to provide additional information. After Part B samples were obtained, it was determined that the extensive results for immunogenicity profiles of 2 doses of 100 ug mRNA-1273 that were obtained during Part A of this study and in Study P301 demonstrated enough immune response data.</population>
          <units>AU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.29" lower_limit="76.89" upper_limit="96.83"/>
                    <measurement group_id="O2" value="109.56" lower_limit="96.79" upper_limit="124.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1069.73" lower_limit="992.92" upper_limit="1152.49"/>
                    <measurement group_id="O2" value="1083.21" lower_limit="1018.75" upper_limit="1151.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)</title>
        <description>The GM titer (microneutralization [MN] and MN50) of serum nAb against SARS-CoV-2 as measured by live virus MN assays is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. For MN, LLOQ was 40 and ULOQ was 1280 at Days 1 (Baseline), 29, 43, and 57. For MN50, LLOQ was 91.10 and ULOQ was 2031.87 at Days 1 (Baseline), 29, 43, and 57. For MN, LLOQ was 160 and ULOQ was 1280 at Day 209. For MN50, LLOQ was 318.46 and ULOQ was 1917.83 at Day 209. The 95% CI was calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM titer, then back transformed to the original scale for presentation.</description>
        <time_frame>Days 1 (Baseline), 29, 43, 57, and 209</time_frame>
        <population>PP Set included randomized participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: 50 ug mRNA-1273</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Part A: 100 ug mRNA-1273</title>
            <description>Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Placebo</title>
            <description>Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)</title>
          <description>The GM titer (microneutralization [MN] and MN50) of serum nAb against SARS-CoV-2 as measured by live virus MN assays is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. For MN, LLOQ was 40 and ULOQ was 1280 at Days 1 (Baseline), 29, 43, and 57. For MN50, LLOQ was 91.10 and ULOQ was 2031.87 at Days 1 (Baseline), 29, 43, and 57. For MN, LLOQ was 160 and ULOQ was 1280 at Day 209. For MN50, LLOQ was 318.46 and ULOQ was 1917.83 at Day 209. The 95% CI was calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM titer, then back transformed to the original scale for presentation.</description>
          <population>PP Set included randomized participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.</population>
          <units>titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="189"/>
                <count group_id="O3" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MN, Day 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                    <count group_id="O2" value="189"/>
                    <count group_id="O3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.6" lower_limit="20.0" upper_limit="21.2"/>
                    <measurement group_id="O2" value="20.6" lower_limit="19.7" upper_limit="21.5"/>
                    <measurement group_id="O3" value="20.8" lower_limit="20.1" upper_limit="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MN, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="187"/>
                    <count group_id="O3" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.2" lower_limit="94.9" upper_limit="132.7"/>
                    <measurement group_id="O2" value="149.6" lower_limit="127.3" upper_limit="175.9"/>
                    <measurement group_id="O3" value="21.9" lower_limit="20.5" upper_limit="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MN, Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1145.4" lower_limit="1101.3" upper_limit="1191.1"/>
                    <measurement group_id="O2" value="1185.8" lower_limit="1142.9" upper_limit="1230.3"/>
                    <measurement group_id="O3" value="21.2" lower_limit="20.1" upper_limit="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MN, Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="177"/>
                    <count group_id="O3" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1090.6" lower_limit="1038.9" upper_limit="1144.9"/>
                    <measurement group_id="O2" value="1095.5" lower_limit="1041.5" upper_limit="1152.2"/>
                    <measurement group_id="O3" value="21.8" lower_limit="20.4" upper_limit="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MN, Day 209</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="254.4" lower_limit="219.4" upper_limit="294.9"/>
                    <measurement group_id="O2" value="354.8" lower_limit="309.2" upper_limit="407.2"/>
                    <measurement group_id="O3" value="85.3" lower_limit="80.6" upper_limit="90.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MN50, Day 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                    <count group_id="O2" value="189"/>
                    <count group_id="O3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.500" lower_limit="45.425" upper_limit="47.600"/>
                    <measurement group_id="O2" value="46.684" lower_limit="44.957" upper_limit="48.477"/>
                    <measurement group_id="O3" value="47.109" lower_limit="45.745" upper_limit="48.512"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MN50, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="187"/>
                    <count group_id="O3" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="173.750" lower_limit="148.550" upper_limit="203.225"/>
                    <measurement group_id="O2" value="227.433" lower_limit="194.207" upper_limit="266.343"/>
                    <measurement group_id="O3" value="49.231" lower_limit="46.355" upper_limit="52.285"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MN50, Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1761.660" lower_limit="1690.216" upper_limit="1836.124"/>
                    <measurement group_id="O2" value="1813.480" lower_limit="1741.280" upper_limit="1888.673"/>
                    <measurement group_id="O3" value="48.059" lower_limit="45.820" upper_limit="50.408"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MN50, Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="177"/>
                    <count group_id="O3" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1632.442" lower_limit="1550.245" upper_limit="1718.998"/>
                    <measurement group_id="O2" value="1656.064" lower_limit="1570.464" upper_limit="1746.330"/>
                    <measurement group_id="O3" value="49.141" lower_limit="46.267" upper_limit="52.194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MN50, Day 209</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="401.508" lower_limit="350.667" upper_limit="459.720"/>
                    <measurement group_id="O2" value="538.798" lower_limit="472.772" upper_limit="614.045"/>
                    <measurement group_id="O3" value="167.002" lower_limit="159.249" upper_limit="175.133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Titer of SARS-CoV-2-Specific nAb</title>
        <description>The GM titer (50% inhibitory dose [ID50], 80% inhibitory dose [ID80]) of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 18.5 and ULOQ was 45118 for IC50. LLOQ was 14.3 and ULOQ was 10232 for ID80. The 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.</description>
        <time_frame>Days 1 (Baseline), 29, and 181</time_frame>
        <population>PP Set. Number Analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the &quot;Part B: Placebo then 100 ug mRNA&quot; arm were not tested and no data were generated as results were not thought to provide additional information. After Part B samples were obtained, it was determined that the extensive results for immunogenicity profiles of 2 doses of 100 ug mRNA-1273 that were obtained during Part A of this study and in Study P301 demonstrated enough immune response data.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
          </group>
          <group group_id="O2">
            <title>Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Titer of SARS-CoV-2-Specific nAb</title>
          <description>The GM titer (50% inhibitory dose [ID50], 80% inhibitory dose [ID80]) of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 18.5 and ULOQ was 45118 for IC50. LLOQ was 14.3 and ULOQ was 10232 for ID80. The 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.</description>
          <population>PP Set. Number Analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the &quot;Part B: Placebo then 100 ug mRNA&quot; arm were not tested and no data were generated as results were not thought to provide additional information. After Part B samples were obtained, it was determined that the extensive results for immunogenicity profiles of 2 doses of 100 ug mRNA-1273 that were obtained during Part A of this study and in Study P301 demonstrated enough immune response data.</population>
          <units>titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ID50, Day 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.658" lower_limit="88.282" upper_limit="124.070"/>
                    <measurement group_id="O2" value="150.224" lower_limit="125.726" upper_limit="179.495"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1834.309" lower_limit="1600.233" upper_limit="2102.623"/>
                    <measurement group_id="O2" value="1951.735" lower_limit="1729.606" upper_limit="2202.392"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50, Day 181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="915.331" lower_limit="622.504" upper_limit="1345.904"/>
                    <measurement group_id="O2" value="673.273" lower_limit="578.167" upper_limit="784.025"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80, Day 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.646" lower_limit="33.789" upper_limit="46.518"/>
                    <measurement group_id="O2" value="55.686" lower_limit="47.459" upper_limit="65.341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="696.085" lower_limit="609.203" upper_limit="795.358"/>
                    <measurement group_id="O2" value="736.617" lower_limit="661.040" upper_limit="820.835"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80, Day 181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="291.791" lower_limit="203.597" upper_limit="418.189"/>
                    <measurement group_id="O2" value="228.635" lower_limit="197.044" upper_limit="265.291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Titer of SARS-CoV-2-Specific nAb</title>
        <description>The GM titer (ID50, ID80) of nAb against SARS-CoV-2 pseudotyped viruses (original strain and beta variant [B.1.351]) as measured by pseudovirus nAb assay is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. For NAb ID50 Titers, LLOQ was 18.5 and ULOQ was 45118. For NAb ID80 Titers, LLOQ was 14.3 and ULOQ was 10232. For NAb ID50 Titers against B.1.351, LLOQ was 19.5 and ULOQ was 385.7. For NAb ID80 Titers against B.1.351, LLOQ was 12.5 and ULOQ was 102.2. The 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation.</description>
        <time_frame>Days 1 (Baseline), 8, 15, 29, and 181</time_frame>
        <population>PP Set included participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: 20 ug mRNA-1273.351</title>
            <description>Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part C: 50 ug mRNA-1273.351</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Titer of SARS-CoV-2-Specific nAb</title>
          <description>The GM titer (ID50, ID80) of nAb against SARS-CoV-2 pseudotyped viruses (original strain and beta variant [B.1.351]) as measured by pseudovirus nAb assay is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. For NAb ID50 Titers, LLOQ was 18.5 and ULOQ was 45118. For NAb ID80 Titers, LLOQ was 14.3 and ULOQ was 10232. For NAb ID50 Titers against B.1.351, LLOQ was 19.5 and ULOQ was 385.7. For NAb ID80 Titers against B.1.351, LLOQ was 12.5 and ULOQ was 102.2. The 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation.</description>
          <population>PP Set included participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.</population>
          <units>titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ID50 Against Original Strain, Day 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="196.107" lower_limit="133.338" upper_limit="288.424"/>
                    <measurement group_id="O2" value="156.011" lower_limit="80.546" upper_limit="302.180"/>
                    <measurement group_id="O3" value="79.572" lower_limit="53.625" upper_limit="118.074"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against Original Strain, Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1089.901" lower_limit="748.146" upper_limit="1587.770"/>
                    <measurement group_id="O2" value="1568.894" lower_limit="1030.722" upper_limit="2388.062"/>
                    <measurement group_id="O3" value="1183.096" lower_limit="900.313" upper_limit="1554.700"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against Original Strain, Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2221.382" lower_limit="1434.353" upper_limit="3440.255"/>
                    <measurement group_id="O2" value="1725.415" lower_limit="1212.131" upper_limit="2456.053"/>
                    <measurement group_id="O3" value="3082.946" lower_limit="1891.502" upper_limit="5024.874"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against Original Strain, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1808.133" lower_limit="1323.211" upper_limit="2470.767"/>
                    <measurement group_id="O2" value="1757.179" lower_limit="1117.782" upper_limit="2762.324"/>
                    <measurement group_id="O3" value="3691.896" lower_limit="2330.908" upper_limit="5847.548"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against Original Strain, Day 181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="512.129" lower_limit="303.261" upper_limit="864.853"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against Original Strain, Day 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.279" lower_limit="53.035" upper_limit="109.712"/>
                    <measurement group_id="O2" value="56.344" lower_limit="33.804" upper_limit="93.911"/>
                    <measurement group_id="O3" value="30.774" lower_limit="21.565" upper_limit="43.915"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against Original Strain, Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="448.109" lower_limit="300.430" upper_limit="668.381"/>
                    <measurement group_id="O2" value="500.158" lower_limit="341.180" upper_limit="733.214"/>
                    <measurement group_id="O3" value="458.435" lower_limit="351.348" upper_limit="598.161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against Original Strain, Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="730.018" lower_limit="509.454" upper_limit="1046.073"/>
                    <measurement group_id="O2" value="678.926" lower_limit="462.561" upper_limit="996.498"/>
                    <measurement group_id="O3" value="947.774" lower_limit="647.781" upper_limit="1386.696"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against Original Strain, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="632.263" lower_limit="460.549" upper_limit="868.001"/>
                    <measurement group_id="O2" value="615.967" lower_limit="397.103" upper_limit="955.460"/>
                    <measurement group_id="O3" value="1156.267" lower_limit="743.617" upper_limit="1797.907"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against Original Strain, Day 181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="182.837" lower_limit="108.300" upper_limit="308.673"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against B.1.351, Day 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.574" lower_limit="28.832" upper_limit="72.036"/>
                    <measurement group_id="O2" value="32.026" lower_limit="19.758" upper_limit="51.911"/>
                    <measurement group_id="O3" value="18.338" lower_limit="13.572" upper_limit="24.776"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against B.1.351, Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="919.281" lower_limit="592.738" upper_limit="1425.720"/>
                    <measurement group_id="O2" value="1088.511" lower_limit="670.315" upper_limit="1767.610"/>
                    <measurement group_id="O3" value="706.141" lower_limit="456.010" upper_limit="1093.475"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against B.1.351, Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1088.432" lower_limit="736.353" upper_limit="1608.854"/>
                    <measurement group_id="O2" value="1113.392" lower_limit="652.885" upper_limit="1898.716"/>
                    <measurement group_id="O3" value="1166.830" lower_limit="760.230" upper_limit="1790.895"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against B.1.351, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1537.029" lower_limit="1066.352" upper_limit="2215.458"/>
                    <measurement group_id="O2" value="1116.885" lower_limit="714.119" upper_limit="1746.813"/>
                    <measurement group_id="O3" value="1129.955" lower_limit="742.454" upper_limit="1719.699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against B.1.351, Day 181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="141.773" lower_limit="76.471" upper_limit="262.839"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against B.1.351, Day 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.403" lower_limit="10.870" upper_limit="27.863"/>
                    <measurement group_id="O2" value="15.046" lower_limit="10.088" upper_limit="22.442"/>
                    <measurement group_id="O3" value="8.326" lower_limit="6.727" upper_limit="10.306"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against B.1.351, Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="289.360" lower_limit="196.260" upper_limit="426.626"/>
                    <measurement group_id="O2" value="313.644" lower_limit="203.582" upper_limit="483.210"/>
                    <measurement group_id="O3" value="225.475" lower_limit="160.419" upper_limit="316.915"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against B.1.351, Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="435.078" lower_limit="300.742" upper_limit="629.418"/>
                    <measurement group_id="O2" value="371.579" lower_limit="228.889" upper_limit="603.223"/>
                    <measurement group_id="O3" value="413.424" lower_limit="284.856" upper_limit="600.020"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against B.1.351, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="486.398" lower_limit="341.630" upper_limit="692.511"/>
                    <measurement group_id="O2" value="345.827" lower_limit="214.472" upper_limit="557.633"/>
                    <measurement group_id="O3" value="362.540" lower_limit="249.138" upper_limit="527.560"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against B.1.351, Day 181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="55.887" lower_limit="29.969" upper_limit="104.220"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Percentage of Participants With Seroconversion From Baseline</title>
        <description>Based on MN titers and MN50 titers of serum nAb against SARS-CoV-2 as measured by live virus MN assays, percentage of participants with seroconversion from baseline are reported with 2-sided 95% CI using the Clopper-Pearson method at each post-baseline timepoint. Seroconversion at a participant level was defined as a change of nAb titer from below the limit of detection (LOD) or LLOQ to equal to or above LOD or LLOQ (respectively), or a 4-times or higher titer ratio in participants with pre-existing nAb titers. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. For MN, LLOQ was 40 and ULOQ was 1280. For MN50, LLOQ was 91.10 and ULOQ was 2031.87.</description>
        <time_frame>Days 29, 43, and 57</time_frame>
        <population>PP Set included randomized participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: 50 ug mRNA-1273</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O2">
            <title>Part A: 100 ug mRNA-1273</title>
            <description>Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Placebo</title>
            <description>Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Percentage of Participants With Seroconversion From Baseline</title>
          <description>Based on MN titers and MN50 titers of serum nAb against SARS-CoV-2 as measured by live virus MN assays, percentage of participants with seroconversion from baseline are reported with 2-sided 95% CI using the Clopper-Pearson method at each post-baseline timepoint. Seroconversion at a participant level was defined as a change of nAb titer from below the limit of detection (LOD) or LLOQ to equal to or above LOD or LLOQ (respectively), or a 4-times or higher titer ratio in participants with pre-existing nAb titers. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. For MN, LLOQ was 40 and ULOQ was 1280. For MN50, LLOQ was 91.10 and ULOQ was 2031.87.</description>
          <population>PP Set included randomized participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="168"/>
                <count group_id="O2" value="180"/>
                <count group_id="O3" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MN Titer, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="168"/>
                    <count group_id="O2" value="180"/>
                    <count group_id="O3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.0" lower_limit="70.9" upper_limit="84.0"/>
                    <measurement group_id="O2" value="88.9" lower_limit="83.4" upper_limit="93.1"/>
                    <measurement group_id="O3" value="1.7" lower_limit="0.3" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MN Titer, Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="141"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="97.4" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O3" value="0.6" lower_limit="0.0" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MN Titer, Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="152"/>
                    <count group_id="O3" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O3" value="1.8" lower_limit="0.4" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MN50 Titer, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="168"/>
                    <count group_id="O2" value="180"/>
                    <count group_id="O3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.5" lower_limit="57.8" upper_limit="72.6"/>
                    <measurement group_id="O2" value="76.7" lower_limit="69.8" upper_limit="82.6"/>
                    <measurement group_id="O3" value="1.1" lower_limit="0.1" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MN50 Titer, Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="141"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="97.4" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O3" value="0.6" lower_limit="0.0" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MN50 Titer, Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="152"/>
                    <count group_id="O3" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O3" value="1.8" lower_limit="0.4" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Percentage of Participants With Seroconversion From Baseline</title>
        <description>Based on ID50 and ID80 titers of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay, % of participants with seroconversion from baseline reported with 2-sided 95% CI using Clopper-Pearson method at each postbaseline timepoint. Seroconversion at participant level defined as change of nAb titer from below LOD or LLOQ to equal to or above LOD or LLOQ (respectively) or 4-times or higher titer ratio in participants with preexisting nAb titers. Antibody values &lt;LLOQ replaced by 0.5*LLOQ. Values &gt;ULOQ converted to ULOQ. LLOQ: 18.5 and ULOQ: 45118 for IC50. LLOQ: 14.3 and ULOQ: 10232 for ID80. 95% CI calculated based on t-distribution of log-transformed values for GMT, then back transformed to original scale for presentation. PP Set: participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.</description>
        <time_frame>Days 29 and 181</time_frame>
        <population>PP Set. Number Analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the &quot;Part B: Placebo then 100 ug mRNA&quot; arm were not tested and no data were generated as results were not thought to provide additional information. After Part B samples were obtained, it was determined that the extensive results for immunogenicity profiles of 2 doses of 100 ug mRNA-1273 that were obtained during Part A of this study and in Study P301 demonstrated enough immune response data.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
          </group>
          <group group_id="O2">
            <title>Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273</title>
            <description>Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Percentage of Participants With Seroconversion From Baseline</title>
          <description>Based on ID50 and ID80 titers of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay, % of participants with seroconversion from baseline reported with 2-sided 95% CI using Clopper-Pearson method at each postbaseline timepoint. Seroconversion at participant level defined as change of nAb titer from below LOD or LLOQ to equal to or above LOD or LLOQ (respectively) or 4-times or higher titer ratio in participants with preexisting nAb titers. Antibody values &lt;LLOQ replaced by 0.5*LLOQ. Values &gt;ULOQ converted to ULOQ. LLOQ: 18.5 and ULOQ: 45118 for IC50. LLOQ: 14.3 and ULOQ: 10232 for ID80. 95% CI calculated based on t-distribution of log-transformed values for GMT, then back transformed to original scale for presentation. PP Set: participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.</description>
          <population>PP Set. Number Analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the &quot;Part B: Placebo then 100 ug mRNA&quot; arm were not tested and no data were generated as results were not thought to provide additional information. After Part B samples were obtained, it was determined that the extensive results for immunogenicity profiles of 2 doses of 100 ug mRNA-1273 that were obtained during Part A of this study and in Study P301 demonstrated enough immune response data.</population>
          <units>percentage of participants</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ID50, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.4" lower_limit="86.8" upper_limit="96.2"/>
                    <measurement group_id="O2" value="87.9" lower_limit="81.6" upper_limit="92.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50, Day 181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.6" lower_limit="65.7" upper_limit="92.3"/>
                    <measurement group_id="O2" value="54.4" lower_limit="46.0" upper_limit="62.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.2" lower_limit="90.3" upper_limit="98.0"/>
                    <measurement group_id="O2" value="93.3" lower_limit="88.0" upper_limit="96.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80, Day 181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.9" lower_limit="62.7" upper_limit="90.4"/>
                    <measurement group_id="O2" value="53.7" lower_limit="45.3" upper_limit="62.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Percentage of Participants With Seroconversion From Baseline</title>
        <description>Based on ID50 titers and ID80 titers of nAb against SARS-CoV-2 pseudotyped viruses (original strain and beta variant [B.1.351]) as measured by pseudovirus nAb assay, percentage of participants with seroconversion from baseline are reported with 2-sided 95% CI using Clopper-Pearson method at each post-baseline timepoint. Seroconversion at participant level defined as a change of nAb titer from below LOD or LLOQ ≥LOD or LLOQ (respectively), or a 4-times or higher titer ratio in participants with pre-existing nAb titers. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values &gt;ULOQ were converted to ULOQ. NAb ID50 Titers: LLOQ was 18.5 and ULOQ was 45118. NAb ID80 Titers: LLOQ was 14.3 and ULOQ was 10232. NAb ID50 Titers against B.1.351: LLOQ was 19.5 and ULOQ was 385.7. NAb ID80 Titers against B.1.351: LLOQ was 12.5 and ULOQ was 102.2. 95% CI calculated based on t-distribution of log-transformed values for GMT, then back transformed to original scale for presentation.</description>
        <time_frame>Days 8, 15, 29, and 181</time_frame>
        <population>PP Set included participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: 20 ug mRNA-1273.351</title>
            <description>Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part C: 50 ug mRNA-1273.351</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Percentage of Participants With Seroconversion From Baseline</title>
          <description>Based on ID50 titers and ID80 titers of nAb against SARS-CoV-2 pseudotyped viruses (original strain and beta variant [B.1.351]) as measured by pseudovirus nAb assay, percentage of participants with seroconversion from baseline are reported with 2-sided 95% CI using Clopper-Pearson method at each post-baseline timepoint. Seroconversion at participant level defined as a change of nAb titer from below LOD or LLOQ ≥LOD or LLOQ (respectively), or a 4-times or higher titer ratio in participants with pre-existing nAb titers. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values &gt;ULOQ were converted to ULOQ. NAb ID50 Titers: LLOQ was 18.5 and ULOQ was 45118. NAb ID80 Titers: LLOQ was 14.3 and ULOQ was 10232. NAb ID50 Titers against B.1.351: LLOQ was 19.5 and ULOQ was 385.7. NAb ID80 Titers against B.1.351: LLOQ was 12.5 and ULOQ was 102.2. 95% CI calculated based on t-distribution of log-transformed values for GMT, then back transformed to original scale for presentation.</description>
          <population>PP Set included participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.</population>
          <units>percentage of participants</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ID50 Against Original Strain, Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.4" lower_limit="24.4" upper_limit="71.1"/>
                    <measurement group_id="O2" value="78.9" lower_limit="54.4" upper_limit="93.9"/>
                    <measurement group_id="O3" value="100" lower_limit="83.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against Original Strain, Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.9" lower_limit="54.4" upper_limit="93.9"/>
                    <measurement group_id="O2" value="90.0" lower_limit="68.3" upper_limit="98.8"/>
                    <measurement group_id="O3" value="95.0" lower_limit="75.1" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against Original Strain, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.2" lower_limit="60.4" upper_limit="96.6"/>
                    <measurement group_id="O2" value="95.0" lower_limit="75.1" upper_limit="99.9"/>
                    <measurement group_id="O3" value="100" lower_limit="83.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against Original Strain, Day 181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="38.9" lower_limit="17.3" upper_limit="64.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against Original Strain, Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.4" lower_limit="43.4" upper_limit="87.4"/>
                    <measurement group_id="O2" value="84.2" lower_limit="60.4" upper_limit="96.6"/>
                    <measurement group_id="O3" value="95.0" lower_limit="75.1" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against Original Strain, Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.2" lower_limit="60.4" upper_limit="96.6"/>
                    <measurement group_id="O2" value="95.0" lower_limit="75.1" upper_limit="99.9"/>
                    <measurement group_id="O3" value="100" lower_limit="83.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against Original Strain, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.2" lower_limit="60.4" upper_limit="96.6"/>
                    <measurement group_id="O2" value="95.0" lower_limit="75.1" upper_limit="99.9"/>
                    <measurement group_id="O3" value="95.0" lower_limit="75.1" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against Original Strain, Day 181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="38.9" lower_limit="17.3" upper_limit="64.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against B.1.351, Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="82.4" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="82.4" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100" lower_limit="83.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against B.1.351, Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.7" lower_limit="74.0" upper_limit="99.9"/>
                    <measurement group_id="O2" value="100" lower_limit="83.2" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100" lower_limit="83.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against B.1.351, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="82.4" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="83.2" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100" lower_limit="83.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID50 Against B.1.351, Day 181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="61.1" lower_limit="35.7" upper_limit="82.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against B.1.351, Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.7" lower_limit="74.0" upper_limit="99.9"/>
                    <measurement group_id="O2" value="94.7" lower_limit="74.0" upper_limit="99.9"/>
                    <measurement group_id="O3" value="100" lower_limit="83.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against B.1.351, Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.7" lower_limit="74.0" upper_limit="99.9"/>
                    <measurement group_id="O2" value="100" lower_limit="83.2" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100" lower_limit="83.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against B.1.351, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="82.4" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="83.2" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100" lower_limit="83.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ID80 Against B.1.351, Day 181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="55.6" lower_limit="30.8" upper_limit="78.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part C: Level of SARS-CoV-2-Specific bAb as Measured by MSD</title>
        <description>The GM level of SARS-CoV-2 protein antibody against B.1.351, as measured by MSD MULTIPLEX is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 18 and ULOQ was 4200000. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.</description>
        <time_frame>Days 1 (Baseline), 8, 15, and 29</time_frame>
        <population>PP Set included participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: 20 ug mRNA-1273.351</title>
            <description>Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>50 ug mRNA-1273.351</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture</title>
            <description>Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Level of SARS-CoV-2-Specific bAb as Measured by MSD</title>
          <description>The GM level of SARS-CoV-2 protein antibody against B.1.351, as measured by MSD MULTIPLEX is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 18 and ULOQ was 4200000. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.</description>
          <population>PP Set included participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.</population>
          <units>AU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59742.3" lower_limit="43057.8" upper_limit="82891.8"/>
                    <measurement group_id="O2" value="44921.5" lower_limit="28539.6" upper_limit="70706.5"/>
                    <measurement group_id="O3" value="33409.8" lower_limit="25264.8" upper_limit="44180.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="240180.0" lower_limit="166361.1" upper_limit="346754.3"/>
                    <measurement group_id="O2" value="267002.2" lower_limit="199939.9" upper_limit="356558.2"/>
                    <measurement group_id="O3" value="228572.0" lower_limit="178986.7" upper_limit="291894.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="297880.2" lower_limit="224089.6" upper_limit="395969.4"/>
                    <measurement group_id="O2" value="418215.3" lower_limit="311988.7" upper_limit="560610.2"/>
                    <measurement group_id="O3" value="384521.1" lower_limit="282461.4" upper_limit="523457.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="297962.7" lower_limit="227337.5" upper_limit="390528.5"/>
                    <measurement group_id="O2" value="345765.9" lower_limit="251640.5" upper_limit="475098.5"/>
                    <measurement group_id="O3" value="367714.1" lower_limit="268913.2" upper_limit="502815.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Month 15</time_frame>
      <desc>Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part A: 50 ug mRNA-1273</title>
          <description>Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.</description>
        </group>
        <group group_id="E2">
          <title>Part A: 100 ug mRNA-1273</title>
          <description>Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.</description>
        </group>
        <group group_id="E3">
          <title>Part A: Placebo</title>
          <description>Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.</description>
        </group>
        <group group_id="E4">
          <title>Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273</title>
          <description>Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
        </group>
        <group group_id="E5">
          <title>Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273</title>
          <description>Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.</description>
        </group>
        <group group_id="E6">
          <title>Part B: Placebo Then 100 ug mRNA-1273</title>
          <description>Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.</description>
        </group>
        <group group_id="E7">
          <title>Part C: 20 ug mRNA-1273.351</title>
          <description>Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.</description>
        </group>
        <group group_id="E8">
          <title>Part C: 50 ug mRNA-1273.351</title>
          <description>Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.</description>
        </group>
        <group group_id="E9">
          <title>Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture</title>
          <description>Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 23.0</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="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Peptic ulcer perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma stage IV</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Struck by lightning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous system cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion missed</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA version 23.0</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="200"/>
                <counts group_id="E2" subjects_affected="76" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="94" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="51" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="62" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="70" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="9" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Diastolic dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness unilateral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Excessive cerumen production</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyperoestrogenism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Thyroid cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Thyroid disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Macular fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Irritable bowel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Oesophageal food impaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tongue discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Oral disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pulpless tooth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Axillary pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Allergy to arthropod sting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Suspected COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Infected bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tinea pedis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Asymptomatic COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sinusitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cryptosporidiosis infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastrointestinal bacterial overgrowth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Onychomycosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Labyrinthitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Breast injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Chemical burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Corneal abrasion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Epicondylitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Foreign body in eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Heat exhaustion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Muscle contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Muscle rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Post-traumatic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nail avulsion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tendon injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Fascial rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Blood pressure diastolic increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Haematocrit increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Haemoglobin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hormone level abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Platelet count increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Staphylococcus test positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Blood testosterone decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Computerised tomogram coronary artery abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Heart rate decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vitamin D decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Heart rate increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Glycosylated haemoglobin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Insulin resistance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vitamin B12 deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Plantar fasciitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Axillary mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Exostosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Haematoma muscle</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Osteopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sjogren's syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Benign neoplasm of skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Ageusia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Restless legs syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Attention deficit hyperactivity disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypertonic bladder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Postmenopausal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Testicular cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nasal pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pharyngeal erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pharyngeal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nasal septum deviation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hirsutism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dermatitis exfoliative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diastolic hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="173"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Moderna Clinical Trials Support Center</name_or_title>
      <organization>ModernaTX, Inc.</organization>
      <phone>1-877-777-7187</phone>
      <email>clinicaltrials@modernatx.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/NCT04405076
org study id: mRNA-1273-P201
secondary id: 75A50120C00034
nct id: NCT04405076
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose
      levels of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-COV-2) vaccine in
      adults 18 years of age or older.
This is a 3-part Phase 2a study, with Part A (Blinded Phase), Part B (Open-label
      Interventional Phase), and Part C (Rollover Proof of Concept).

      Participants in Part A are blinded to their treatment assignment, with participants receiving
      either 2 active mRNA-1273 vaccine doses or placebo. Part B of the study is designed to offer
      participants to be unblinded so that participants who received placebo in Part A can request
      2 doses of open-label mRNA-1273 vaccine. Additionally, participants who originally received 1
      or 2 doses of mRNA-1273 (50 microgram [μg] or 100 μg vaccine) during Part A, will have the
      opportunity to request to receive a single booster dose of mRNA-1273.

      Part C will be a proof-of-concept rollover study to evaluate a vaccine to treat mutations of
      SARS-CoV2, such as the S-protein of the B.1.351 variant. Part C will include approximately 60
      participants, who are currently enrolled in Moderna's Phase 3 mRNA-1273-P301 study
      (NCT04470427), have already been unblinded, and have previously received 2 doses of mRNA-1273
      at least 6 months earlier. At enrollment into Part C of this study, their participation in
      mRNA-1273-P301 study will be terminated. Part C will evaluate the safety and immunogenicity
      of 2 dose levels (20 µg and 50 µg) of mRNA-1273.351 and mRNA-1273/mRNA-1273.351 mixture (50
      µg total), given as a single booster dose.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: Part A is observer-blind. During Part B participants may request to be unblinded by scheduling a Participant Decision clinic visit. Part C is open-label.
measure: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
time frame: 7 days post-vaccination
description: Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
measure: Number of Participants With Unsolicited AEs
time frame: Up to 28 days post-vaccination
description: An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Month 15), regardless of causality, is located in the Reported "Adverse Events" section.
measure: Number of Participants With Medically-Attended Adverse Events (MAAEs)
time frame: Up to Month 15
description: An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
measure: Number of Participants With SAEs
time frame: Up to Month 15
description: An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
measure: Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
time frame: Days 1 (Baseline), 29, 43, 57, and 209
description: The geometric mean (GM) level of VAC58 spike immunoglobulin G (IgG) antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ if actual values were not available. LLOQ was 1 and ULOQ was 2052. The 95% confidence intervals (CIs) were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.
measure: Part B: Level of SARS-CoV-2-Specific bAb as Measured by ELISA
time frame: Days 1 (Baseline) and 29
description: The GM level of VAC65 spike IgG antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 1 and ULOQ was 2052. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.
measure: Part C: Level of SARS-CoV-2-Specific bAb as Measured by MSD
time frame: Days 1 (Baseline), 8, 15, and 29
description: The GM level of SARS-CoV-2 protein antibody against B.1.351, as measured by MSD MULTIPLEX is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 18 and ULOQ was 4200000. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.
measure: Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
time frame: Days 1 (Baseline), 29, 43, 57, and 209
description: The GM titer (microneutralization [MN] and MN50) of serum nAb against SARS-CoV-2 as measured by live virus MN assays is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. For MN, LLOQ was 40 and ULOQ was 1280 at Days 1 (Baseline), 29, 43, and 57. For MN50, LLOQ was 91.10 and ULOQ was 2031.87 at Days 1 (Baseline), 29, 43, and 57. For MN, LLOQ was 160 and ULOQ was 1280 at Day 209. For MN50, LLOQ was 318.46 and ULOQ was 1917.83 at Day 209. The 95% CI was calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM titer, then back transformed to the original scale for presentation.
measure: Part B: Titer of SARS-CoV-2-Specific nAb
time frame: Days 1 (Baseline), 29, and 181
description: The GM titer (50% inhibitory dose [ID50], 80% inhibitory dose [ID80]) of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 18.5 and ULOQ was 45118 for IC50. LLOQ was 14.3 and ULOQ was 10232 for ID80. The 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.
measure: Part C: Titer of SARS-CoV-2-Specific nAb
time frame: Days 1 (Baseline), 8, 15, 29, and 181
description: The GM titer (ID50, ID80) of nAb against SARS-CoV-2 pseudotyped viruses (original strain and beta variant [B.1.351]) as measured by pseudovirus nAb assay is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. For NAb ID50 Titers, LLOQ was 18.5 and ULOQ was 45118. For NAb ID80 Titers, LLOQ was 14.3 and ULOQ was 10232. For NAb ID50 Titers against B.1.351, LLOQ was 19.5 and ULOQ was 385.7. For NAb ID80 Titers against B.1.351, LLOQ was 12.5 and ULOQ was 102.2. The 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation.
measure: Part A: Percentage of Participants With Seroconversion From Baseline
time frame: Days 29, 43, and 57
description: Based on MN titers and MN50 titers of serum nAb against SARS-CoV-2 as measured by live virus MN assays, percentage of participants with seroconversion from baseline are reported with 2-sided 95% CI using the Clopper-Pearson method at each post-baseline timepoint. Seroconversion at a participant level was defined as a change of nAb titer from below the limit of detection (LOD) or LLOQ to equal to or above LOD or LLOQ (respectively), or a 4-times or higher titer ratio in participants with pre-existing nAb titers. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. For MN, LLOQ was 40 and ULOQ was 1280. For MN50, LLOQ was 91.10 and ULOQ was 2031.87.
measure: Part B: Percentage of Participants With Seroconversion From Baseline
time frame: Days 29 and 181
description: Based on ID50 and ID80 titers of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay, % of participants with seroconversion from baseline reported with 2-sided 95% CI using Clopper-Pearson method at each postbaseline timepoint. Seroconversion at participant level defined as change of nAb titer from below LOD or LLOQ to equal to or above LOD or LLOQ (respectively) or 4-times or higher titer ratio in participants with preexisting nAb titers. Antibody values <LLOQ replaced by 0.5*LLOQ. Values >ULOQ converted to ULOQ. LLOQ: 18.5 and ULOQ: 45118 for IC50. LLOQ: 14.3 and ULOQ: 10232 for ID80. 95% CI calculated based on t-distribution of log-transformed values for GMT, then back transformed to original scale for presentation. PP Set: participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.
measure: Part C: Percentage of Participants With Seroconversion From Baseline
time frame: Days 8, 15, 29, and 181
description: Based on ID50 titers and ID80 titers of nAb against SARS-CoV-2 pseudotyped viruses (original strain and beta variant [B.1.351]) as measured by pseudovirus nAb assay, percentage of participants with seroconversion from baseline are reported with 2-sided 95% CI using Clopper-Pearson method at each post-baseline timepoint. Seroconversion at participant level defined as a change of nAb titer from below LOD or LLOQ ≥LOD or LLOQ (respectively), or a 4-times or higher titer ratio in participants with pre-existing nAb titers. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values >ULOQ were converted to ULOQ. NAb ID50 Titers: LLOQ was 18.5 and ULOQ was 45118. NAb ID80 Titers: LLOQ was 14.3 and ULOQ was 10232. NAb ID50 Titers against B.1.351: LLOQ was 19.5 and ULOQ was 385.7. NAb ID80 Titers against B.1.351: LLOQ was 12.5 and ULOQ was 102.2. 95% CI calculated based on t-distribution of log-transformed values for GMT, then back transformed to original scale for presentation.
arm group label: mRNA-1273: Dose 50 microgram (ug) - Participants Aged 18-54 years
arm group type: Experimental
description: Part A: Participants aged 18-54 years will receive 1 intramuscular (IM) injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
Part B: Participants aged 18-54 years who choose to be unblinded and received 50 ug mRNA-1273 during Part A, will receive 1 IM injection of mRNA-1273 (booster dose) on Day 1.
arm group label: mRNA-1273: Dose 50 ug - Participants Aged 55+ years
arm group type: Experimental
description: Part A: Participants aged 55+ years will receive 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
Part B: Participants aged 55+ years who choose to be unblinded and received 50 ug mRNA-1273 during Part A, will receive 1 IM injection of mRNA-1273 (booster dose) on Day 1.
arm group label: mRNA-1273: Dose 100 ug - Participants Aged 18-54 years
arm group type: Experimental
description: Part A: Participants aged 18-54 years will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
Part B: Participants aged 18-54 years who choose to be unblinded and received 100 ug mRNA-1273 during Part A, will receive 1 IM injection of mRNA-1273 (booster dose) on Day 1.
arm group label: mRNA-1273: Dose 100 ug - Participants Aged 55+ years
arm group type: Experimental
description: Part A: Participants aged 55+ years will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
Part B: Participants aged 55+ years who choose to be unblinded and received 100 ug mRNA-1273 during Part A, will receive 1 IM injection of mRNA-1273 (booster dose) on Day 1.
arm group label: Placebo (Part A) and mRNA-1273 100 ug (Part B) - Participants Aged 18-54 years
arm group type: Placebo Comparator
description: Part A: Participants aged 18-54 years will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
Part B: Participants aged 18-54 who choose to be unblinded and received mRNA-1273-matching placebo during Part A, will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and Day 29.
arm group label: Placebo (Part A) and mRNA-1273 100 ug (Part B) - Participants Aged 55+ years
arm group type: Placebo Comparator
description: Part A: Participants aged 55+ years will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
Part B: Participants aged 55+ years who choose to be unblinded and received mRNA-1273-matching placebo during Part A, will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and Day 29.
arm group label: mRNA 1273.351 20 ug (Part C)
arm group type: Experimental
description: Part C: Participants will receive 1 IM booster dose of 20 ug of mRNA 1273.351 on Day 1.
arm group label: mRNA 1273.351 50 ug (Part C)
arm group type: Experimental
description: Part C: Participants will receive 1 IM booster dose of 50 ug of mRNA 1273.351 on Day 1.
arm group label: mRNA-1273/mRNA-1273.351 mixture (Part C)
arm group type: Experimental
description: Part C: Participants will receive 1 IM booster dose of 50 ug of mRNA-1273/mRNA-1273.351 mixture on Day 1.
intervention type: Biological
intervention name: Biological: mRNA-1273
description: Sterile liquid for injection
arm group label: Placebo (Part A) and mRNA-1273 100 ug (Part B) - Participants Aged 18-54 years
arm group label: Placebo (Part A) and mRNA-1273 100 ug (Part B) - Participants Aged 55+ years
arm group label: mRNA-1273/mRNA-1273.351 mixture (Part C)
arm group label: mRNA-1273: Dose 100 ug - Participants Aged 18-54 years
arm group label: mRNA-1273: Dose 100 ug - Participants Aged 55+ years
arm group label: mRNA-1273: Dose 50 microgram (ug) - Participants Aged 18-54 years
arm group label: mRNA-1273: Dose 50 ug - Participants Aged 55+ years
intervention type: Biological
intervention name: Placebo
description: 0.9% sodium chloride (normal saline) injection
arm group label: Placebo (Part A) and mRNA-1273 100 ug (Part B) - Participants Aged 18-54 years
arm group label: Placebo (Part A) and mRNA-1273 100 ug (Part B) - Participants Aged 55+ years
intervention type: Biological
intervention name: mRNA-1273.351
description: Sterile liquid for injection
arm group label: mRNA 1273.351 20 ug (Part C)
arm group label: mRNA 1273.351 50 ug (Part C)
arm group label: mRNA-1273/mRNA-1273.351 mixture (Part C)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 