<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/NCT03829657</url>
  </required_header>
  <id_info>
    <org_study_id>0170</org_study_id>
    <secondary_id>2018-003941-41</secondary_id>
    <nct_id>NCT03829657</nct_id>
  </id_info>
  <brief_title>Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure</brief_title>
  <acronym>REDWOOD</acronym>
  <official_title>A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Theravance Biopharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Theravance Biopharma</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>
      A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating&#xD;
      Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 3, multi-center, randomized withdrawal study to evaluate the sustained benefit in&#xD;
      efficacy and safety of ampreloxetine in subjects with primary autonomic failures (MSA, PD, or&#xD;
      PAF) and symptomatic nOH. The study consists of 3 periods: (i) 16-week open-label (OL)&#xD;
      treatment with ampreloxetine, (ii) 6-week randomized placebo-controlled treatment, and (iii)&#xD;
      2-week follow-up (only for patients who do not enroll in Study 0171 (long-term extension&#xD;
      safety study)).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Stopped early due to company decision. Company decision based on analysis results in&#xD;
    TD-9855-0169.&#xD;
  </why_stopped>
  <start_date type="Actual">February 22, 2019</start_date>
  <completion_date type="Actual">November 10, 2021</completion_date>
  <primary_completion_date type="Actual">November 10, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Open Label Extension followed by Randomized Parallel Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period</measure>
    <time_frame>6-week randomized withdrawal period (Week 16 to Week 22)</time_frame>
    <description>Treatment failure was defined as proportion of participants who met the following criteria at Week 6 following randomization: Change (worsening) from baseline in Question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA#1) score of 1.0 point and worsening of disease severity as assessed by a 1-point change in Patient Global Impression of Severity (PGI-S). OHSA Question #1 assessed dizziness, lightheadedness, feeling faint, or feeling like you might blackout. PGI-S assessed patient's impression of disease severity.&#xD;
Least squares mean here is the model-based proportion of participants with treatment failure using logistic regression.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">203</enrollment>
  <condition>Symptomatic Neurogenic Orthostatic Hypotension</condition>
  <condition>MSA</condition>
  <condition>Parkinson's Disease (PD)</condition>
  <condition>Pure Autonomic Failure (PAF)</condition>
  <arm_group>
    <arm_group_label>ampreloxetine (Open Label (OL))</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ampreloxetine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After completing the OL, participants randomized to ampreloxetine will receive single, oral, daily dose of active drug for a further 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After completing the OL, participants randomized to Placebo will receive single, oral, daily dose of placebo for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ampreloxetine</intervention_name>
    <description>Oral tablet, QD (Daily)</description>
    <arm_group_label>ampreloxetine</arm_group_label>
    <arm_group_label>ampreloxetine (Open Label (OL))</arm_group_label>
    <other_name>TD-9855</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral tablet, QD</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (For 0169 Completers Group):&#xD;
&#xD;
          -  Subject has completed 4 weeks of double blind treatment in Study 0169 (V6) and, in the&#xD;
             opinion of the Investigator, could benefit from continued treatment with&#xD;
             ampreloxetine. Only subjects with OHSA#1 score of ≤7 will be eligible for&#xD;
             randomization for the double-blind treatment period.&#xD;
&#xD;
          -  Subject has a minimum of 80% study medication compliance in Study 0169.&#xD;
&#xD;
        Inclusion Criteria (For De Novo Group):&#xD;
&#xD;
          -  Subject is male or female and at least 30 years old.&#xD;
&#xD;
          -  Subject must meet the diagnostic criteria of symptomatic nOH, as demonstrated by a&#xD;
             sustained reduction in BP of ≥20 mm Hg (systolic) or ≥10 mm Hg (diastolic) within 3&#xD;
             min of being tilted-up ≥60o from a supine position as determined by a tilt-table test.&#xD;
&#xD;
          -  Subject must score at least a 4 on the OHSA#1 at V1.&#xD;
&#xD;
          -  For subjects with PD only: Subject has a diagnosis of PD according to the United&#xD;
             Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria (1992).&#xD;
&#xD;
          -  For subjects with MSA only: Subject has a diagnosis of possible or probable MSA of the&#xD;
             Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman&#xD;
             Criteria (2008).&#xD;
&#xD;
          -  For subjects with PAF only: Subject has documented impaired autonomic reflexes,&#xD;
             including the Valsalva maneuver performed within 24 months from the date of&#xD;
             randomization&#xD;
&#xD;
          -  Subject has plasma Norepinephrine (NE) levels ≥ 100 pg/mL after being in seated&#xD;
             position for 30 minutes.&#xD;
&#xD;
        Exclusion Criteria (For 0169 Completers Group):&#xD;
&#xD;
          -  Subject has a medical, laboratory, or surgical issue(s) deemed by the investigator to&#xD;
             be clinically significant.&#xD;
&#xD;
          -  Subject has an uncooperative attitude or reasonable likelihood of non-compliance with&#xD;
             the protocol.&#xD;
&#xD;
          -  Subject has a concurrent disease or condition that, in the opinion of the&#xD;
             investigator, would confound or interfere with study participation or evaluation of&#xD;
             safety, tolerability, or pharmacokinetics of the study drug.&#xD;
&#xD;
        Exclusion Criteria (For De Novo Group):&#xD;
&#xD;
          -  Subject has a known systemic illness known to produce autonomic neuropathy, including&#xD;
             but not limited to amyloidosis, and autoimmune neuropathies.&#xD;
&#xD;
          -  Subject has a known intolerance to other NRIs or serotonin norepinephrine reuptake&#xD;
             inhibitors (SNRIs).&#xD;
&#xD;
          -  Subject currently uses concomitant antihypertensive medication for the treatment of&#xD;
             essential hypertension unrelated to autonomic dysfunction.&#xD;
&#xD;
          -  Subject has used strong CYP1A2 inhibitors or inducers within 7 days or 5 half-lives,&#xD;
             whichever is longer, prior to V1 or requires concomitant use until the follow-up&#xD;
             visit.&#xD;
&#xD;
          -  Subject has changed dose, frequency, or type of prescribed medication for orthostatic&#xD;
             hypotension within 7 days prior to V1.&#xD;
&#xD;
               -  Midodrine and droxidopa (if applicable) must be tapered off at least 7 days prior&#xD;
                  to V1.&#xD;
&#xD;
          -  Subject has known or suspected alcohol or substance abuse within the past 12 months&#xD;
             (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision&#xD;
             [DSM-IV-TR®] definition of alcohol or substance abuse).&#xD;
&#xD;
          -  Subject has a clinically unstable coronary artery disease, or has had a major&#xD;
             cardiovascular or neurological event in the past 6 months.&#xD;
&#xD;
          -  Subject has used any monoamine oxidase inhibitor (MAO-I) within 14 days prior to V1.&#xD;
&#xD;
          -  Subject has a history of untreated closed angle glaucoma, or treated closed angle&#xD;
             glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk&#xD;
             to the subject.&#xD;
&#xD;
          -  Subject has any significant uncontrolled cardiac arrhythmia.&#xD;
&#xD;
          -  Subject has a Montreal Cognitive Assessment (MoCA) ≤23.&#xD;
&#xD;
          -  Subject is unable or unwilling to complete all protocol specified procedures including&#xD;
             questionnaires.&#xD;
&#xD;
          -  Subject had a myocardial infarction in the past 6 months or has current unstable&#xD;
             angina.&#xD;
&#xD;
          -  Subject has known congestive heart failure (New York Heart Association [NYHA] Class 3&#xD;
             or 4).&#xD;
&#xD;
          -  Subject has a clinically significant abnormal laboratory finding (e.g., alanine&#xD;
             aminotransferase [ALT] or aspartate aminotransferase [AST] &gt;3.0 x upper limit of&#xD;
             normal [ULN]; blood bilirubin [total] &gt;1.5 x ULN; estimated glomerular filtration rate&#xD;
             (eGFR) &lt;30 mL/min/1.73 m2, or any abnormal laboratory value that could interfere with&#xD;
             safety of the subject).&#xD;
&#xD;
          -  Subject has demonstrated a history of lifetime suicidal ideation and/or suicidal&#xD;
             behavior, as outlined by the Columbia Suicide Severity Rating Scale&#xD;
             (C-SSRS)(Baseline/Screening Version). Subject should be assessed by the rater for risk&#xD;
             of suicide and the subject's appropriateness for inclusion in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Monitor</last_name>
    <role>Study Director</role>
    <affiliation>Theravance Biopharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner Sun Health Research Institute</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC San Diego Movement Disorder Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Neuroscience Health Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Springs Neurological Associates, PC</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkinson's Disease and Movement Disorders Center</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SFM Clinical Research, LLC</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33487</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurostudies, Inc</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University Health System</name>
      <address>
        <city>Glenview</city>
        <state>Illinois</state>
        <zip>60026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center Research Institute, Inc.</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Baptist Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Medical Center (UCGNI)</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University - Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University Hospital</name>
      <address>
        <city>McLean</city>
        <state>Virginia</state>
        <zip>22101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Northwest Research</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Concord Hospital, Neurosciences Department</name>
      <address>
        <city>Concord</city>
        <state>New South Wales</state>
        <zip>02139</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Melbourne Hospital Neurology Department</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perron Institute for Neurological and Translational Science</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitat Innsbruck, Abteilung fur Neurologie</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Tulln Abteilung fur Neurologie</name>
      <address>
        <city>Tulln</city>
        <zip>3430</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders</name>
      <address>
        <city>Sofia</city>
        <zip>1113</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary Teaching Research and Wellness Building</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Neurological Institute &amp; Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3A 2B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bispebjerg Hospital</name>
      <address>
        <city>Copenhagen</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense Universitetshospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Tallinn Central Hospital</name>
      <address>
        <city>Tallinn</city>
        <zip>10138</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Astra Team Clinic</name>
      <address>
        <city>Tallinn</city>
        <zip>11315</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tartu University Hospital</name>
      <address>
        <city>Tartu</city>
        <zip>50406</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nîmes - Hôpital Caremeau</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Campus Virchow-Klinikum, Klinik fur Neurologie</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Christian Oehlwein</name>
      <address>
        <city>Gera</city>
        <zip>7551</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem, Neurologiai Klinika</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center, Beilinson Campus</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaplan Medical Center</name>
      <address>
        <city>Rehovot</city>
        <zip>76100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita di Bologna-Clinica Neurologica - Dipt di Scienze Neurologiche Ospedale Bellaria</name>
      <address>
        <city>Bologna</city>
        <zip>40139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Gaspare Rodolico)</name>
      <address>
        <city>Catania</city>
        <zip>95125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita degli studi Gabriele D' Annunzio Chieti</name>
      <address>
        <city>Chieti</city>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Pisana- Ospedale S. Chiara, U.O. di Neurologia - Neurofisiopatologia</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia</name>
      <address>
        <city>Roma</city>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU San Giovanni di Dio e Ruggi d'Aragona</name>
      <address>
        <city>Salerno</city>
        <zip>84131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Santa Maria</name>
      <address>
        <city>Terni</city>
        <zip>05100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Zealand Brain Research Institute</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specjalistyczna Praktyka Lekarska, Prof. Grzegorz Opala</name>
      <address>
        <city>Katowice</city>
        <zip>40-588</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krakowska Akademia Neurologii Sp. Zo.o. Centrum Neurologii Klinicznej</name>
      <address>
        <city>Kraków</city>
        <zip>31-505</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut Zdrowia dr Boczarska-Jedynak</name>
      <address>
        <city>Oswiecim</city>
        <zip>32-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NEURO-CARE Sp. z o.o. Sp. Komandytowa</name>
      <address>
        <city>Siemianowice Śląskie</city>
        <zip>41-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ETG Warszawa</name>
      <address>
        <city>Warszawa</city>
        <zip>02-777</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specjalistyczne Gabinety sp. z o.o.</name>
      <address>
        <city>Warszawa</city>
        <zip>30-539</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital da Senhora da Oliveira Guimarães</name>
      <address>
        <city>Guimarães</city>
        <zip>4835-044</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNS-Campus Neurologico Senior</name>
      <address>
        <city>Torres Vedras</city>
        <zip>2560-280</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Petersburg State Budgetary Institution of Healthcare City Hospital #40 of Kurortnyi Region</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Sestroretsk</state>
        <zip>197706</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency</name>
      <address>
        <city>Krasnoyarsk</city>
        <zip>660037</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital #34</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Neurological Center Sibneiromed, LLC</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630091</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev of the MOH of the Russian Federation</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>192019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI of Science Institute of Human Brain named after N .P. Bekhtereva of Russian Academy of Sciences</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197376</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Mutua de Terrasa</name>
      <address>
        <city>Terrassa</city>
        <state>Barcelona</state>
        <zip>08221</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Cruces</name>
      <address>
        <city>Bilbao</city>
        <state>Vizcaya</state>
        <zip>48903</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Noncommercial Enterprise City Policlinic #9 of Kharkiv City Council</name>
      <address>
        <city>Kharkiv</city>
        <zip>61172</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital</name>
      <address>
        <city>Lviv</city>
        <zip>79010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Institution Acad. O.I. Yuschenko VRPsH Vinnytsia M.I. Pyrogov NMU Ch of ND with the Course of Neurosurgery</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon and Exeter Hospital NHS Trust</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cognition Health Unit 2</name>
      <address>
        <city>Plymouth</city>
        <state>Devon</state>
        <zip>PL6 8BT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salford Royal NHS Foundation Trust</name>
      <address>
        <city>Salford</city>
        <state>Greater Manchester</state>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Centre, William Harvey Heart Centre</name>
      <address>
        <city>London</city>
        <zip>EC1M 6BQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Re:Cognition Health Ltd</name>
      <address>
        <city>London</city>
        <zip>W1G 9JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The National Hospital for Neurology &amp; Neurosurgery</name>
      <address>
        <city>London</city>
        <zip>WC1N 3BG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Argentina</country>
  </removed_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <results_first_submitted>November 8, 2022</results_first_submitted>
  <results_first_submitted_qc>December 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 20, 2023</results_first_posted>
  <last_update_submitted>December 29, 2022</last_update_submitted>
  <last_update_submitted_qc>December 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Symptomatic Neurogenic Orthostatic Hypotension</keyword>
  <keyword>symptomatic nOH</keyword>
  <keyword>multiple symptom atrophy</keyword>
  <keyword>MSA</keyword>
  <keyword>Parkinson's disease</keyword>
  <keyword>PD</keyword>
  <keyword>pure autonomic failure</keyword>
  <keyword>PAF</keyword>
  <keyword>orthostatic hypotension</keyword>
  <keyword>OH</keyword>
  <keyword>REDWOOD</keyword>
  <keyword>ampreloxetine</keyword>
  <keyword>low blood pressure</keyword>
  <keyword>dizziness</keyword>
  <keyword>fainting</keyword>
  <keyword>blacking out</keyword>
  <keyword>lightheadedness</keyword>
  <keyword>norepinephrine</keyword>
  <keyword>hypotension</keyword>
  <keyword>Neurogenic Orthostatic Hypotension</keyword>
  <keyword>nOH</keyword>
  <keyword>170</keyword>
  <keyword>0170</keyword>
  <keyword>145</keyword>
  <keyword>0145</keyword>
  <keyword>TD-9855</keyword>
  <keyword>TD9855</keyword>
  <keyword>Parkinsonism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Hypotension, Orthostatic</mesh_term>
    <mesh_term>Pure Autonomic Failure</mesh_term>
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.</ipd_description>
  </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>August 5, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03829657/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>December 14, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03829657/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled from February 2019 to November 2021. 203 participants were enrolled in the open label (OL) treatment period, including 170 participants from the 0169 study (NCT number: NCT03750552). 128 participants who completed the OL treatment period continued in the randomized withdrawal (RW) treatment period.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>OL Treatment Period: 0169 Placebo Rollover</title>
          <description>Participants who received the placebo in study 0169, received 10 mg oral ampreloxetine once a day (QD) for up to 16 weeks.</description>
        </group>
        <group group_id="P2">
          <title>OL Treatment Period: 0169 Ampreloxetine Rollover</title>
          <description>Participants who received ampreloxetine in study 0169, received 10 mg oral ampreloxetine QD for up to 16 weeks.</description>
        </group>
        <group group_id="P3">
          <title>OL Treatment Period: De Novo</title>
          <description>Participants with symptomatic neurogenic orthostatic hypotension (nOH) who met all applicable study inclusion criteria and none of the applicable exclusion criteria, received 10 mg oral ampreloxetine QD for up to 16 weeks. These participants did not roll over from the 0169 study.</description>
        </group>
        <group group_id="P4">
          <title>RW Treatment Period: Placebo</title>
          <description>Participants who completed the OL treatment period and were randomized to receive oral placebo QD for a further 6 weeks in the RW treatment period.</description>
        </group>
        <group group_id="P5">
          <title>RW Treatment Period: Ampreloxetine</title>
          <description>Participants who completed the OL treatment period and were randomized to receive 10 mg oral ampreloxetine QD for a further 6 weeks in the RW treatment period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>OL Treatment Period (Week 1 to Week 16)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="85"/>
                <participants group_id="P3" count="33"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="64"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" 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="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failure to Meet Day 29 Continuation Criterion</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>RW Treatment Period (Week 16 to Week 24)</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="64"/>
                <participants group_id="P5" count="64"/>
              </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="61"/>
                <participants group_id="P5" count="58"/>
              </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="3"/>
                <participants group_id="P5" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</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="2"/>
                <participants group_id="P5" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <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="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous</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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>OL Treatment Period Safety Analysis Set: all enrolled participants who received at least 1 dose of ampreloxetine during the OL period.</population>
      <group_list>
        <group group_id="B1">
          <title>OL Treatment Period: 0169 Placebo Rollover</title>
          <description>Participants who received the placebo in study 0169, received 10 mg oral ampreloxetine once a day (QD) for up to 16 weeks.</description>
        </group>
        <group group_id="B2">
          <title>OL Treatment Period: 0169 Ampreloxetine Rollover</title>
          <description>Participants who received ampreloxetine in study 0169, received 10 mg oral ampreloxetine QD for up to 16 weeks.</description>
        </group>
        <group group_id="B3">
          <title>OL Treatment Period: De Novo</title>
          <description>Participants with symptomatic neurogenic orthostatic hypotension (nOH) who met all applicable study inclusion criteria and none of the applicable exclusion criteria, received 10 mg oral ampreloxetine QD for up to 16 weeks. These participants did not roll over from the 0169 study.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="83"/>
            <count group_id="B2" value="85"/>
            <count group_id="B3" value="32"/>
            <count group_id="B4" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.2" spread="9.35"/>
                    <measurement group_id="B2" value="68.2" spread="9.00"/>
                    <measurement group_id="B3" value="69.0" spread="7.97"/>
                    <measurement group_id="B4" value="68.4" spread="8.96"/>
                  </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="22"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="140"/>
                  </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="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="185"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</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="3"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period</title>
        <description>Treatment failure was defined as proportion of participants who met the following criteria at Week 6 following randomization: Change (worsening) from baseline in Question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA#1) score of 1.0 point and worsening of disease severity as assessed by a 1-point change in Patient Global Impression of Severity (PGI-S). OHSA Question #1 assessed dizziness, lightheadedness, feeling faint, or feeling like you might blackout. PGI-S assessed patient's impression of disease severity.&#xD;
Least squares mean here is the model-based proportion of participants with treatment failure using logistic regression.</description>
        <time_frame>6-week randomized withdrawal period (Week 16 to Week 22)</time_frame>
        <population>RW Treatment Period Full Analysis Set: all randomized participants who received at least 1 dose of study medication (ampreloxetine or placebo) following randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>RW Treatment Period: Placebo</title>
            <description>Participants who completed the OL treatment period and were randomized to receive oral placebo QD for a further 6 weeks in the RW treatment period.</description>
          </group>
          <group group_id="O2">
            <title>RW Treatment Period: Ampreloxetine</title>
            <description>Participants who completed the OL treatment period and were randomized to receive 10 mg oral ampreloxetine QD for a further 6 weeks in the RW treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period</title>
          <description>Treatment failure was defined as proportion of participants who met the following criteria at Week 6 following randomization: Change (worsening) from baseline in Question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA#1) score of 1.0 point and worsening of disease severity as assessed by a 1-point change in Patient Global Impression of Severity (PGI-S). OHSA Question #1 assessed dizziness, lightheadedness, feeling faint, or feeling like you might blackout. PGI-S assessed patient's impression of disease severity.&#xD;
Least squares mean here is the model-based proportion of participants with treatment failure using logistic regression.</description>
          <population>RW Treatment Period Full Analysis Set: all randomized participants who received at least 1 dose of study medication (ampreloxetine or placebo) following randomization.</population>
          <units>Proportion of participants</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" spread="0.068"/>
                    <measurement group_id="O2" value="0.30" spread="0.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.196</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.27</ci_lower_limit>
            <ci_upper_limit>1.29</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>OL Treatment Period: Day 1 to Week 16 (plus a 2 week follow-up period); RW Treatment Period: Week 16 to Week 24 (plus a 2 week follow-up period)</time_frame>
      <desc>OL Safety Analysis Set: all enrolled participants who received at least 1 dose of ampreloxetine during the OL period.&#xD;
RW Treatment Safety Analysis Set: all randomized participants who received at least 1 dose of study medication (ampreloxetine or placebo) following randomization. The Safety Analysis Set and FAS were identical for the RW treatment period.</desc>
      <group_list>
        <group group_id="E1">
          <title>OL Treatment Period: 0169 Placebo Rollover</title>
          <description>Participants who received the placebo in study 0169, received 10 mg oral ampreloxetine once a day (QD) for up to 16 weeks.</description>
        </group>
        <group group_id="E2">
          <title>OL Treatment Period: 0169 Ampreloxetine Rollover</title>
          <description>Participants who received ampreloxetine in study 0169, received 10 mg oral ampreloxetine QD for up to 16 weeks.</description>
        </group>
        <group group_id="E3">
          <title>OL Treatment Period: De Novo</title>
          <description>Participants with symptomatic neurogenic orthostatic hypotension (nOH) who met all applicable study inclusion criteria and none of the applicable exclusion criteria, received 10 mg oral ampreloxetine QD for up to 16 weeks. These participants did not roll over from the 0169 study.</description>
        </group>
        <group group_id="E4">
          <title>RW Treatment Period: Placebo</title>
          <description>Participants who completed the OL treatment period and were randomized to receive oral placebo QD for a further 6 weeks in the RW treatment period.</description>
        </group>
        <group group_id="E5">
          <title>RW Treatment Period: Ampreloxetine</title>
          <description>Participants who completed the OL treatment period and were randomized to receive 10 mg oral ampreloxetine QD for a further 6 weeks in the RW treatment period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Spinal column injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Bulbar palsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Neurological decompensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Subcapsular renal haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hip arthroplasty</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="17" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Anaemia vitamin B12 deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bundle branch block left</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypermetropia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Open angle glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vitreous floaters</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Retching</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to vaccine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Back injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Post procedural discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Colonoscopy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Glomerular filtration rate abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Haematocrit decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Cystoscopy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Mobility decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Haemangioma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>On and off phenomenon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dizziness exertional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypokinesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Multiple system atrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Oromandibular dystonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Radial nerve palsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Restless legs syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Spasmodic dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Speech disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Migraine with aura</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bulbar palsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bruxism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hallucination, visual</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypomania</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Urinary hesitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Calculus bladder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Gynaecomastia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Priapism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Endometrial hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Uterine enlargement</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hair growth rate abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hand dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Palmar erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Walking disability</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Supine hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>White coat hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Diastolic hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="64"/>
              </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>
    <limitations_and_caveats>De Novo participants in the OL treatment period had limited follow-up due to early termination of the study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Medical Monitor</name_or_title>
      <organization>Theravance Biopharma Ireland Limited</organization>
      <phone>855 633 8479 ext +1</phone>
      <email>medinfo@theravance.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/NCT03829657
org study id: 0170
secondary id: 2018-003941-41
nct id: NCT03829657
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating
      Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
Phase 3, multi-center, randomized withdrawal study to evaluate the sustained benefit in
      efficacy and safety of ampreloxetine in subjects with primary autonomic failures (MSA, PD, or
      PAF) and symptomatic nOH. The study consists of 3 periods: (i) 16-week open-label (OL)
      treatment with ampreloxetine, (ii) 6-week randomized placebo-controlled treatment, and (iii)
      2-week follow-up (only for patients who do not enroll in Study 0171 (long-term extension
      safety study)).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Open Label Extension followed by Randomized Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period
time frame: 6-week randomized withdrawal period (Week 16 to Week 22)
description: Treatment failure was defined as proportion of participants who met the following criteria at Week 6 following randomization: Change (worsening) from baseline in Question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA#1) score of 1.0 point and worsening of disease severity as assessed by a 1-point change in Patient Global Impression of Severity (PGI-S). OHSA Question #1 assessed dizziness, lightheadedness, feeling faint, or feeling like you might blackout. PGI-S assessed patient's impression of disease severity.
Least squares mean here is the model-based proportion of participants with treatment failure using logistic regression.
arm group label: ampreloxetine (Open Label (OL))
arm group type: Experimental
description: Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 16 weeks.
arm group label: ampreloxetine
arm group type: Experimental
description: After completing the OL, participants randomized to ampreloxetine will receive single, oral, daily dose of active drug for a further 6 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: After completing the OL, participants randomized to Placebo will receive single, oral, daily dose of placebo for 6 weeks.
intervention type: Drug
intervention name: ampreloxetine
description: Oral tablet, QD (Daily)
arm group label: ampreloxetine
arm group label: ampreloxetine (Open Label (OL))
other name: TD-9855
intervention type: Drug
intervention name: Placebo
description: Oral tablet, QD
arm group label: Placebo
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Monitor
role: Study Director
affiliation: Theravance Biopharma
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country: Australia
country: Austria
country: Bulgaria
country: Canada
country: Denmark
country: Estonia
country: France
country: Germany
country: Hungary
country: Israel
country: Italy
country: New Zealand
country: Poland
country: Portugal
country: Russian Federation
country: Spain
country: Ukraine
country: United Kingdom
country: United States
country: Argentina
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Hypotension, Orthostatic
mesh term: Pure Autonomic Failure
mesh term: Hypotension
sharing ipd: No
ipd description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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limitations and caveats: De Novo participants in the OL treatment period had limited follow-up due to early termination of the study.
point of contact: 