<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/NCT02203838</url>
  </required_header>
  <id_info>
    <org_study_id>RB-US-13-0005</org_study_id>
    <nct_id>NCT02203838</nct_id>
  </id_info>
  <brief_title>Long Term Study of RBP 7000 in the Treatment of Subjects With Schizophrenia</brief_title>
  <official_title>An Open-Label, Long-Term Safety and Tolerability Study of RBP-7000 in the Treatment of Subjects With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indivior Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indivior Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 3, open label study administering RBP-7000 in the treatment of patients with&#xD;
      schizophrenia. Study will assess the long-term safety and tolerability of RBP-7000&#xD;
      subcutaneous (SC) injections in subjects with schizophrenia and to continue collecting&#xD;
      clinical outcome data with RBP-7000 SC injections in subjects with schizophrenia using the&#xD;
      Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity Illness&#xD;
      (CGI-S) scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients to be screened must be diagnosed with schizophrenia with a designated score based on&#xD;
      the PANSS, as confirmed by a State, Assessability, Face, Ecological and Rule (SAFER)&#xD;
      interview. &quot;De novo&quot; patients are patients who are already receiving 3- or 4-mg oral&#xD;
      risperidone/day and will not have to complete the &quot;run-in&quot; or &quot;conversion&quot; phases (see below)&#xD;
      and will be assigned to receive RBP-7000 after eligibility has been confirmed. Patients who&#xD;
      completed the double-blind, placebo-controlled, efficacy study of RBP-7000 (RB-US-09-0010,&#xD;
      NCT02109562), conducted in patients with acute schizophrenia (referred to as &quot;roll-over&quot;&#xD;
      patients) will be screened.&#xD;
&#xD;
      All patients will be assigned the 120 mg dose of RBP-7000, which is subject to a one-time&#xD;
      down-titration to 90-mg RBP-7000 for tolerability, at the investigator's discretion. Patients&#xD;
      receiving the 90-mg dose of RBP-7000 who exhibit a worsening in psychiatric symptoms,&#xD;
      confirmed by a total PANSS score &gt;70 or a 20% increase in the PANSS score from the previous&#xD;
      assessment at the 120-mg dose level (before the dose was decreased to 90 mg), can receive a&#xD;
      one-time, up-titration back to 120-mg RBP-7000 at the discretion of the investigator.&#xD;
&#xD;
      &quot;De novo&quot; patients entering into the study are those patients who did not participate in&#xD;
      study RB-US-09-0010 (NCT02109562) and are allocated into three groups with different&#xD;
      pre-study procedures to prepare for the treatment period:&#xD;
&#xD;
        -  &quot;Run-in&quot; patients are patients who are not already receiving oral risperidone (as no&#xD;
           other antipsychotic medications are allowed during study participation) and will begin a&#xD;
           14-day run-in period by titrating up to a dose of 3 or 4 mg oral risperidone/day before&#xD;
           the first injection of RBP-7000.&#xD;
&#xD;
        -  &quot;Conversion&quot; patients are patients who are receiving oral risperidone doses other than 3&#xD;
           or 4mg/day and will begin a 7-day conversion period to achieve an oral risperidone dose&#xD;
           level of 3 or 4-mg before the first injection of RBP-7000, only if clinically indicated.&#xD;
&#xD;
        -  De novo patients taking an oral risperidone dose of 3 or 4 mg/day prestudy will (once&#xD;
           screened/enrolled) receive the first injection of RBP-7000.&#xD;
&#xD;
      &quot;Roll-over&quot; patients entering into the study are patients who completed 56 days of&#xD;
      double-blind treatment in Study RB-US-09-0010. These patients will be eligible to enter the&#xD;
      current study provided that continuation of treatment is clinically warranted, as judged by&#xD;
      the investigator, and that there have been no significant protocol deviations or clinically&#xD;
      relevant adverse events (AEs) that would preclude inclusion in this study. Roll-over patients&#xD;
      will not undergo the complete screening process and will not require either a run-in or&#xD;
      conversion period with oral risperidone. On Day 1 of the open-label study (which is Day 57 of&#xD;
      Study RB-US-09-0010), patients will receive their first injection (120 mg) of open label&#xD;
      RBP-7000.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participants With Treatment-Emergent Adverse Events (TEAE)</measure>
    <time_frame>Day 1 up to week 52</time_frame>
    <description>An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug.&#xD;
A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants With Injection Site-Related Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Day 1 up to week 52</time_frame>
    <description>An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date.&#xD;
Adverse events were coded using MedDRA version 17.0. Preferred terms linked to injection site AEs are reported. Although a participant may have had 2 or more AEs, the subject is counted only once in each preferred term category. The same subject may appear in different preferred term categories.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants With Markedly Abnormal Weight Gain Anytime During the Study as Compared to Baseline</measure>
    <time_frame>Baseline (Day 0), Treatment (Day 1 up to Week 52)</time_frame>
    <description>Participants who were found to have gain &gt;=7% and &gt;=10% of their baseline weight at any point during the study (including unscheduled assessments) once treatment began.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score to Days 29, 169 and End of Study</measure>
    <time_frame>Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52)</time_frame>
    <description>The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor judgement, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicate improvements in symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores to End of Study</measure>
    <time_frame>Baseline (Day 0), End of Study (approximately Week 52)</time_frame>
    <description>PANSS subscales:&#xD;
Positive scale assesses 7 items: delusions, conceptual disorganization, hallucinations, excitement, grandiosity, suspiciousness/persecution, and hostility. Scale: 7 (absent) to 49 (extreme psychopathology)&#xD;
Negative scale assesses 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Scale: 7 (absent) to 49 (extreme psychopathology)&#xD;
General Psychopathology scale assesses 16 items: somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Scale: 16 (absent) to 112 (extreme psychopathology) Negative change from baseline scores indicate improvements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Global Impression - Severity Scores (CGI-S) to Days 29, 169 and End of Study</measure>
    <time_frame>Baseline (Day 0), Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52)</time_frame>
    <description>The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to &quot;Normal, not at all ill&quot; and a rating of 7 is equivalent to &quot;Among the most extremely ill participants&quot;. Negative change from baseline scores indicate improvement in the severity of illness.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>RBP-7000 - 120-mg dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RBP-7000 120-mg subcutaneous (SC) injections every 28 days for 13 doses as open-label therapy. Patients enter the study as 'roll-over' patients from study RB-US-09-0010, or de novo patients. Pre-study procedures vary for de novo patients depending on previous therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RBP-7000</intervention_name>
    <description>120-mg RBP-7000 dose delivered by subcutaneous injection every 28 days for a total of 13 injections (for roll-over participants, the first two injections took place under study RB-US-09-0010).&#xD;
A one-time down-titration to 90 mg RBP-7000 is permitted at the investigator's discretion should the participant have tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.&#xD;
RBP-7000 is a combination of the ATRIGEL Delivery System and risperidone. The ATRIGEL Delivery System allows for sustained-release of risperidone in a controlled manner.</description>
    <arm_group_label>RBP-7000 - 120-mg dose</arm_group_label>
    <other_name>Risperidone</other_name>
    <other_name>Long-acting Risperidone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        &quot;De Novo&quot; Patients&#xD;
&#xD;
          -  Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4,&#xD;
             text revision (DSM-IV-TR) criteria&#xD;
&#xD;
          -  Total PANSS score &lt;=70 at the time of screening (Visit 1)&#xD;
&#xD;
          -  Otherwise healthy on the basis of physical examinatIon&#xD;
&#xD;
          -  Provided written informed consent&#xD;
&#xD;
        &quot;Roll-over Patients&#xD;
&#xD;
          -  Provided written consent to participate in this study&#xD;
&#xD;
          -  Be considered eligible to enroll based on End of Study (EOS) (Day 57 of Study&#xD;
             RB-US-09-0010) assessments and the medical judgment of the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        &quot;De Novo&quot; Patients&#xD;
&#xD;
          -  Patients taking daily oral risperidone at a dose plus/minus 6 mg/day&#xD;
&#xD;
          -  Patients taking any risperidone or 9-hydroxyrisperidone long-acting injectable&#xD;
             formulation within 120 days of study screening (Visit 1)&#xD;
&#xD;
          -  Patients who have received a long-acting injectable antipsychotic within 120 days of&#xD;
             screening (Visit 1)&#xD;
&#xD;
          -  Patients with evidence or history (in the past six months prior to screening) of a&#xD;
             significant hepatic disorder that may either compromise patient safety or interfere&#xD;
             with the safety and/or outcome evaluation of the study drug, including:&#xD;
&#xD;
               -  Acute or chronic hepatitis, including but not limited to hepatitis B or C&#xD;
&#xD;
               -  Total bilirubin greater than 1.5 times the upper limit of normal (ULN), or&#xD;
&#xD;
               -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2&#xD;
                  times ULN&#xD;
&#xD;
          -  Patients with a history of drug-induced leukopenia&#xD;
&#xD;
          -  Patients with other medical conditions including, but not limited to, history of heart&#xD;
             attack (myocardial infarction) or brain injury (traumatic injury with loss of&#xD;
             consciousness and/or cerebrovascular accident), and clinically significant low blood&#xD;
             pressure or arrhythmias as interpreted by the primary investigator (PI) or medically&#xD;
             qualified sub-investigator&#xD;
&#xD;
          -  Patients with epilepsy or other seizure disorders, Parkinson's disease or dementia&#xD;
&#xD;
        &quot;Roll-over&quot; Patients&#xD;
&#xD;
          -  Patients requiring an inpatient treatment setting at the end of Study RB-US-09-0010&#xD;
&#xD;
          -  Patients with an unstable medical condition developed during Study RB-US-09-0010&#xD;
&#xD;
          -  Women of childbearing potential who have a positive pregnancy test at screening (Visit&#xD;
             1), who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate&#xD;
             contraceptive methods during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Indivior Inc.</last_name>
    <role>Study Director</role>
    <affiliation>Indivior Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Woodland International Research Group, Inc.</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woodland Research Northwest, LLC</name>
      <address>
        <city>Springdale</city>
        <state>Arkansas</state>
        <zip>72764</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Clinical Development</name>
      <address>
        <city>Cerritos</city>
        <state>California</state>
        <zip>90703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synergy EPIC</name>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Behavioral Research Specialists</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Collaborative Neuroscience Network, LLC</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apostle Clinical Trials</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Research Partners</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Excell Research</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNRI-Los Angeles</name>
      <address>
        <city>Pico Rivera</city>
        <state>California</state>
        <zip>90660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNRI-San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center for Clinical Studies</name>
      <address>
        <city>Norwalk</city>
        <state>Connecticut</state>
        <zip>06851</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Clinical Development-Washington DC</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Clinical Research Center</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovative Clinical Research</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Behavioral Clinical Reserach</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Clinical Research Center</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Clinical Resarch Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>iResearch Atlanta</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uptown Research Institute</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Behavioral Health Hospital</name>
      <address>
        <city>Hoffman Estates</city>
        <state>Illinois</state>
        <zip>60169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baber Research Group</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Via Christi Research</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Charles Clinical Trials</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70629</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centerpointe Hospital</name>
      <address>
        <city>Saint Charles</city>
        <state>Missouri</state>
        <zip>63304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Clinical Trials</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altea Research Institute</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRI Lifetree - Marlton Unit</name>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <zip>08053-3426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Behavioral Medical Research of Brooklyn</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurobehavioral Research</name>
      <address>
        <city>Cedarhurst</city>
        <state>New York</state>
        <zip>11516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Clinical Development-Queens</name>
      <address>
        <city>Jamaica</city>
        <state>New York</state>
        <zip>11432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Finger Lakes Clinical Research</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Hope Clinical Research</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of America</name>
      <address>
        <city>Hickory</city>
        <state>North Carolina</state>
        <zip>28601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Insight Clinical Trials LLC</name>
      <address>
        <city>Shaker Heights</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Clinical Research Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cutting Edge Research Group</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keystone Clinical Studies</name>
      <address>
        <city>Norristown</city>
        <state>Pennsylvania</state>
        <zip>19403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRI Lifetree - Philadelphia Unit</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19139</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berks Center for ClinicalResearch</name>
      <address>
        <city>Reading</city>
        <state>Pennsylvania</state>
        <zip>19604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Strategies of Memphis</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FutureSearch Clinical Trials</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Clinical Research, Inc.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78754</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FutureSearch Clinical Trials, L.P.</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pillar Clinical Research</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bayou City Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Research Group</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>August 31, 2018</results_first_submitted>
  <results_first_submitted_qc>August 31, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 28, 2018</results_first_posted>
  <disposition_first_submitted>January 30, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>January 30, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">January 31, 2017</disposition_first_posted>
  <last_update_submitted>August 31, 2018</last_update_submitted>
  <last_update_submitted_qc>August 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Schizophrenic</keyword>
  <keyword>Schizophrenias</keyword>
  <keyword>Risperidone</keyword>
  <keyword>Long-acting Risperidone</keyword>
  <keyword>Atrigel</keyword>
  <keyword>Subcutaneous</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Risperidone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 820 subjects were screened for study participation at 53 sites in the US.&#xD;
Overall, 500 participants were included in the Safety Population: 92 rollover participants and 408 de novo participants.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>De Novo Participants</title>
          <description>Participants who were not part of the previous double-blind study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg of RBP-7000 at the discretion of the investigator.</description>
        </group>
        <group group_id="P2">
          <title>Rollover Placebo</title>
          <description>Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
        </group>
        <group group_id="P3">
          <title>Rollover RBP-7000 90 mg</title>
          <description>Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
        </group>
        <group group_id="P4">
          <title>Rollover RBP-7000 120 mg</title>
          <description>Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="408"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="31"/>
                <participants group_id="P4" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="198"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="210"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population</population>
      <group_list>
        <group group_id="B1">
          <title>De Novo Participants</title>
          <description>Participants who were not part of the previous double-blind study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
        </group>
        <group group_id="B2">
          <title>Rollover Placebo</title>
          <description>Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
        </group>
        <group group_id="B3">
          <title>Rollover RBP-7000 90 mg</title>
          <description>Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
        </group>
        <group group_id="B4">
          <title>Rollover RBP-7000 120 mg</title>
          <description>Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
        </group>
        <group group_id="B5">
          <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="408"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="31"/>
            <count group_id="B4" value="33"/>
            <count group_id="B5" value="500"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="408"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="500"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.7" spread="10.51"/>
                    <measurement group_id="B2" value="44.0" spread="7.33"/>
                    <measurement group_id="B3" value="41.1" spread="9.64"/>
                    <measurement group_id="B4" value="42.3" spread="10.04"/>
                    <measurement group_id="B5" value="45.1" spread="10.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="408"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="500"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>20 years and under</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>21 to 30 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>31 to 40 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="106"/>
                  </measurement_list>
                </category>
                <category>
                  <title>41 to 50 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="163"/>
                  </measurement_list>
                </category>
                <category>
                  <title>51 to 55 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="105"/>
                  </measurement_list>
                </category>
                <category>
                  <title>56 to 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="408"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="500"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="133"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="161"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="275"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="339"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Race</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="408"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="500"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="136"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="292"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="354"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Ethnicity</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="408"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="500"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="371"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="31"/>
                    <measurement group_id="B5" value="455"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="408"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="500"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="92.80" spread="20.989"/>
                    <measurement group_id="B2" value="99.33" spread="25.113"/>
                    <measurement group_id="B3" value="96.72" spread="21.305"/>
                    <measurement group_id="B4" value="94.65" spread="23.994"/>
                    <measurement group_id="B5" value="93.53" spread="21.463"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="408"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="500"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.121" spread="7.104"/>
                    <measurement group_id="B2" value="33.920" spread="8.551"/>
                    <measurement group_id="B3" value="31.926" spread="7.104"/>
                    <measurement group_id="B4" value="31.838" spread="8.341"/>
                    <measurement group_id="B5" value="31.375" spread="7.284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Waist-to-Hip Ratio</title>
          <description>A measurement of abdominal fat.</description>
          <population>Measurement not taken for 10 De Novo participants.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="398"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="490"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.946" spread="0.090"/>
                    <measurement group_id="B2" value="0.936" spread="0.094"/>
                    <measurement group_id="B3" value="0.975" spread="0.059"/>
                    <measurement group_id="B4" value="0.935" spread="0.075"/>
                    <measurement group_id="B5" value="0.946" spread="0.087"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Child-bearing Potential</title>
          <population>Females only</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="133"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="13"/>
                    <count group_id="B5" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Positive and Negative Syndrome Scale (PANSS)</title>
          <description>The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor judgement, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="408"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="500"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.0" spread="8.33"/>
                    <measurement group_id="B2" value="72.9" spread="20.99"/>
                    <measurement group_id="B3" value="76.4" spread="15.99"/>
                    <measurement group_id="B4" value="71.0" spread="13.93"/>
                    <measurement group_id="B5" value="60.9" spread="12.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clinical Global Impression - Severity Scale (CGI-S)</title>
          <description>The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to &quot;Normal, not at all ill&quot; and a rating of 7 is equivalent to &quot;Among the most extremely ill participants&quot;.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="408"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="500"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.3" spread="0.62"/>
                    <measurement group_id="B2" value="3.7" spread="1.09"/>
                    <measurement group_id="B3" value="3.8" spread="0.95"/>
                    <measurement group_id="B4" value="3.3" spread="0.89"/>
                    <measurement group_id="B5" value="3.4" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Participants With Treatment-Emergent Adverse Events (TEAE)</title>
        <description>An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug.&#xD;
A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories.</description>
        <time_frame>Day 1 up to week 52</time_frame>
        <population>Safety population -- participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>De Novo Participants</title>
            <description>Participants who were not part of the previous double-blind study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Rollover Placebo</title>
            <description>Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Rollover RBP-7000 90 mg</title>
            <description>Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O4">
            <title>Rollover RBP-7000 120 mg</title>
            <description>Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Treatment-Emergent Adverse Events (TEAE)</title>
          <description>An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug.&#xD;
A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories.</description>
          <population>Safety population -- participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="408"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 or more TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="306"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=1 TEAE related to study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="232"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=1 serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=1 serious and related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE leading to dose modification</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE leading to discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE leading to death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants With Injection Site-Related Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date.&#xD;
Adverse events were coded using MedDRA version 17.0. Preferred terms linked to injection site AEs are reported. Although a participant may have had 2 or more AEs, the subject is counted only once in each preferred term category. The same subject may appear in different preferred term categories.</description>
        <time_frame>Day 1 up to week 52</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>De Novo Participants</title>
            <description>Participants who were not part of the previous double-blind study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Rollover Placebo</title>
            <description>Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Rollover RBP-7000 90 mg</title>
            <description>Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O4">
            <title>Rollover RBP-7000 120 mg</title>
            <description>Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Injection Site-Related Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date.&#xD;
Adverse events were coded using MedDRA version 17.0. Preferred terms linked to injection site AEs are reported. Although a participant may have had 2 or more AEs, the subject is counted only once in each preferred term category. The same subject may appear in different preferred term categories.</description>
          <population>Safety population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="408"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Injection site pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site nodule</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site induration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site pruritus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site bruising</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site discolouration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Device malfunction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Implant site nodule</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Influenza like illness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infusion site bruising</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site irritation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site ulcer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants With Markedly Abnormal Weight Gain Anytime During the Study as Compared to Baseline</title>
        <description>Participants who were found to have gain &gt;=7% and &gt;=10% of their baseline weight at any point during the study (including unscheduled assessments) once treatment began.</description>
        <time_frame>Baseline (Day 0), Treatment (Day 1 up to Week 52)</time_frame>
        <population>Safety population of study participants with a baseline weight recorded and at least one post-treatment weight recorded.</population>
        <group_list>
          <group group_id="O1">
            <title>De Novo Participants</title>
            <description>Participants who were not part of the previous double-blind study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Rollover Placebo</title>
            <description>Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Rollover RBP-7000 90 mg</title>
            <description>Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O4">
            <title>Rollover RBP-7000 120 mg</title>
            <description>Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Markedly Abnormal Weight Gain Anytime During the Study as Compared to Baseline</title>
          <description>Participants who were found to have gain &gt;=7% and &gt;=10% of their baseline weight at any point during the study (including unscheduled assessments) once treatment began.</description>
          <population>Safety population of study participants with a baseline weight recorded and at least one post-treatment weight recorded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="386"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt;=7% increase from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=10% increase from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score to Days 29, 169 and End of Study</title>
        <description>The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor judgement, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicate improvements in symptoms.</description>
        <time_frame>Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52)</time_frame>
        <population>Safety population. Population counts at each timepoint represent participants with an observation at that timepoint (all participants had baseline assessments).</population>
        <group_list>
          <group group_id="O1">
            <title>De Novo Participants</title>
            <description>Participants who were not part of the previous double-blind study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Rollover Placebo</title>
            <description>Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Rollover RBP-7000 90 mg</title>
            <description>Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O4">
            <title>Rollover RBP-7000 120 mg</title>
            <description>Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score to Days 29, 169 and End of Study</title>
          <description>The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor judgement, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicate improvements in symptoms.</description>
          <population>Safety population. Population counts at each timepoint represent participants with an observation at that timepoint (all participants had baseline assessments).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="408"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="362"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="5.70"/>
                    <measurement group_id="O2" value="-4.8" spread="11.11"/>
                    <measurement group_id="O3" value="-8.3" spread="13.43"/>
                    <measurement group_id="O4" value="-2.4" spread="10.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="257"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="6.84"/>
                    <measurement group_id="O2" value="-8.2" spread="18.96"/>
                    <measurement group_id="O3" value="-10.0" spread="14.42"/>
                    <measurement group_id="O4" value="-9.4" spread="9.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="197"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="8.67"/>
                    <measurement group_id="O2" value="-20.2" spread="15.59"/>
                    <measurement group_id="O3" value="-12.5" spread="15.53"/>
                    <measurement group_id="O4" value="-10.9" spread="13.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores to End of Study</title>
        <description>PANSS subscales:&#xD;
Positive scale assesses 7 items: delusions, conceptual disorganization, hallucinations, excitement, grandiosity, suspiciousness/persecution, and hostility. Scale: 7 (absent) to 49 (extreme psychopathology)&#xD;
Negative scale assesses 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Scale: 7 (absent) to 49 (extreme psychopathology)&#xD;
General Psychopathology scale assesses 16 items: somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Scale: 16 (absent) to 112 (extreme psychopathology) Negative change from baseline scores indicate improvements.</description>
        <time_frame>Baseline (Day 0), End of Study (approximately Week 52)</time_frame>
        <population>Safety population. Population counts represent participants with an end of study observation (all participants had baseline assessments).</population>
        <group_list>
          <group group_id="O1">
            <title>De Novo Participants</title>
            <description>Participants who were not part of the previous double-blind study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Rollover Placebo</title>
            <description>Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Rollover RBP-7000 90 mg</title>
            <description>Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O4">
            <title>Rollover RBP-7000 120 mg</title>
            <description>Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores to End of Study</title>
          <description>PANSS subscales:&#xD;
Positive scale assesses 7 items: delusions, conceptual disorganization, hallucinations, excitement, grandiosity, suspiciousness/persecution, and hostility. Scale: 7 (absent) to 49 (extreme psychopathology)&#xD;
Negative scale assesses 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Scale: 7 (absent) to 49 (extreme psychopathology)&#xD;
General Psychopathology scale assesses 16 items: somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Scale: 16 (absent) to 112 (extreme psychopathology) Negative change from baseline scores indicate improvements.</description>
          <population>Safety population. Population counts represent participants with an end of study observation (all participants had baseline assessments).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive subscale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="3.29"/>
                    <measurement group_id="O2" value="-7.8" spread="5.49"/>
                    <measurement group_id="O3" value="-3.7" spread="4.08"/>
                    <measurement group_id="O4" value="-3.7" spread="3.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative subscale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="3.56"/>
                    <measurement group_id="O2" value="-4.0" spread="5.93"/>
                    <measurement group_id="O3" value="-4.1" spread="4.60"/>
                    <measurement group_id="O4" value="-0.9" spread="3.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Psychopathology subscale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="5.00"/>
                    <measurement group_id="O2" value="-8.3" spread="6.95"/>
                    <measurement group_id="O3" value="-4.7" spread="8.99"/>
                    <measurement group_id="O4" value="-6.4" spread="7.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Global Impression - Severity Scores (CGI-S) to Days 29, 169 and End of Study</title>
        <description>The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to &quot;Normal, not at all ill&quot; and a rating of 7 is equivalent to &quot;Among the most extremely ill participants&quot;. Negative change from baseline scores indicate improvement in the severity of illness.</description>
        <time_frame>Baseline (Day 0), Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52)</time_frame>
        <population>Safety population. Population counts at each timepoint represent participants with an observation at that timepoint (all participants had baseline assessments).</population>
        <group_list>
          <group group_id="O1">
            <title>De Novo Participants</title>
            <description>Participants who were not part of the previous double-blind study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Rollover Placebo</title>
            <description>Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Rollover RBP-7000 90 mg</title>
            <description>Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
          <group group_id="O4">
            <title>Rollover RBP-7000 120 mg</title>
            <description>Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Global Impression - Severity Scores (CGI-S) to Days 29, 169 and End of Study</title>
          <description>The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to &quot;Normal, not at all ill&quot; and a rating of 7 is equivalent to &quot;Among the most extremely ill participants&quot;. Negative change from baseline scores indicate improvement in the severity of illness.</description>
          <population>Safety population. Population counts at each timepoint represent participants with an observation at that timepoint (all participants had baseline assessments).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="408"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="362"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.35"/>
                    <measurement group_id="O2" value="-0.3" spread="0.82"/>
                    <measurement group_id="O3" value="-0.2" spread="0.80"/>
                    <measurement group_id="O4" value="-0.1" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="257"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.48"/>
                    <measurement group_id="O2" value="-0.3" spread="1.32"/>
                    <measurement group_id="O3" value="-0.3" spread="0.59"/>
                    <measurement group_id="O4" value="-0.4" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="197"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="0.66"/>
                    <measurement group_id="O2" value="-1.0" spread="1.10"/>
                    <measurement group_id="O3" value="-0.5" spread="0.64"/>
                    <measurement group_id="O4" value="-0.3" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 1 to Week 52</time_frame>
      <group_list>
        <group group_id="E1">
          <title>De Novo Participants</title>
          <description>Participants who were not part of the previous double-blind study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
        </group>
        <group group_id="E2">
          <title>Rollover Placebo</title>
          <description>Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart.&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
        </group>
        <group group_id="E3">
          <title>Rollover RBP-7000 90 mg</title>
          <description>Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
        </group>
        <group group_id="E4">
          <title>Rollover RBP-7000 120 mg</title>
          <description>Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study.&#xD;
Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study).&#xD;
A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Facial paresis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Depressive symptom</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Stress</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Substance-induced psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Pulmonany embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Substance use</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="228" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Injection site nodule</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Akathisia</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Galactorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="408"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="33"/>
              </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>Proposed publications shall be submitted to Sponsor 30 days prior to submission for publication, and may be withheld for an additional period, up to 90 days, to allow Sponsor to file patent applications. If a multicenter publication isn't submitted for publication within 12 months of the conclusion of the Study at all sites, or is published in a shorter period, the results from the institution's site may be published individually.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Director, Clinical Development</name_or_title>
      <organization>Indivior, Inc.</organization>
      <phone>804-379-1090</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02203838
org study id: RB-US-13-0005
nct id: NCT02203838
lead sponsor: 
has dmc: No
This is a Phase 3, open label study administering RBP-7000 in the treatment of patients with
      schizophrenia. Study will assess the long-term safety and tolerability of RBP-7000
      subcutaneous (SC) injections in subjects with schizophrenia and to continue collecting
      clinical outcome data with RBP-7000 SC injections in subjects with schizophrenia using the
      Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity Illness
      (CGI-S) scale.
Patients to be screened must be diagnosed with schizophrenia with a designated score based on
      the PANSS, as confirmed by a State, Assessability, Face, Ecological and Rule (SAFER)
      interview. "De novo" patients are patients who are already receiving 3- or 4-mg oral
      risperidone/day and will not have to complete the "run-in" or "conversion" phases (see below)
      and will be assigned to receive RBP-7000 after eligibility has been confirmed. Patients who
      completed the double-blind, placebo-controlled, efficacy study of RBP-7000 (RB-US-09-0010,
      NCT02109562), conducted in patients with acute schizophrenia (referred to as "roll-over"
      patients) will be screened.

      All patients will be assigned the 120 mg dose of RBP-7000, which is subject to a one-time
      down-titration to 90-mg RBP-7000 for tolerability, at the investigator's discretion. Patients
      receiving the 90-mg dose of RBP-7000 who exhibit a worsening in psychiatric symptoms,
      confirmed by a total PANSS score >70 or a 20% increase in the PANSS score from the previous
      assessment at the 120-mg dose level (before the dose was decreased to 90 mg), can receive a
      one-time, up-titration back to 120-mg RBP-7000 at the discretion of the investigator.

      "De novo" patients entering into the study are those patients who did not participate in
      study RB-US-09-0010 (NCT02109562) and are allocated into three groups with different
      pre-study procedures to prepare for the treatment period:

        -  "Run-in" patients are patients who are not already receiving oral risperidone (as no
           other antipsychotic medications are allowed during study participation) and will begin a
           14-day run-in period by titrating up to a dose of 3 or 4 mg oral risperidone/day before
           the first injection of RBP-7000.

        -  "Conversion" patients are patients who are receiving oral risperidone doses other than 3
           or 4mg/day and will begin a 7-day conversion period to achieve an oral risperidone dose
           level of 3 or 4-mg before the first injection of RBP-7000, only if clinically indicated.

        -  De novo patients taking an oral risperidone dose of 3 or 4 mg/day prestudy will (once
           screened/enrolled) receive the first injection of RBP-7000.

      "Roll-over" patients entering into the study are patients who completed 56 days of
      double-blind treatment in Study RB-US-09-0010. These patients will be eligible to enter the
      current study provided that continuation of treatment is clinically warranted, as judged by
      the investigator, and that there have been no significant protocol deviations or clinically
      relevant adverse events (AEs) that would preclude inclusion in this study. Roll-over patients
      will not undergo the complete screening process and will not require either a run-in or
      conversion period with oral risperidone. On Day 1 of the open-label study (which is Day 57 of
      Study RB-US-09-0010), patients will receive their first injection (120 mg) of open label
      RBP-7000.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Participants With Treatment-Emergent Adverse Events (TEAE)
time frame: Day 1 up to week 52
description: An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug.
A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories.
measure: Participants With Injection Site-Related Treatment-Emergent Adverse Events (TEAEs)
time frame: Day 1 up to week 52
description: An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date.
Adverse events were coded using MedDRA version 17.0. Preferred terms linked to injection site AEs are reported. Although a participant may have had 2 or more AEs, the subject is counted only once in each preferred term category. The same subject may appear in different preferred term categories.
measure: Participants With Markedly Abnormal Weight Gain Anytime During the Study as Compared to Baseline
time frame: Baseline (Day 0), Treatment (Day 1 up to Week 52)
description: Participants who were found to have gain >=7% and >=10% of their baseline weight at any point during the study (including unscheduled assessments) once treatment began.
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score to Days 29, 169 and End of Study
time frame: Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52)
description: The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor judgement, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicate improvements in symptoms.
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores to End of Study
time frame: Baseline (Day 0), End of Study (approximately Week 52)
description: PANSS subscales:
Positive scale assesses 7 items: delusions, conceptual disorganization, hallucinations, excitement, grandiosity, suspiciousness/persecution, and hostility. Scale: 7 (absent) to 49 (extreme psychopathology)
Negative scale assesses 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Scale: 7 (absent) to 49 (extreme psychopathology)
General Psychopathology scale assesses 16 items: somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Scale: 16 (absent) to 112 (extreme psychopathology) Negative change from baseline scores indicate improvements.
measure: Change From Baseline in Clinical Global Impression - Severity Scores (CGI-S) to Days 29, 169 and End of Study
time frame: Baseline (Day 0), Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52)
description: The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Negative change from baseline scores indicate improvement in the severity of illness.
arm group label: RBP-7000 - 120-mg dose
arm group type: Experimental
description: RBP-7000 120-mg subcutaneous (SC) injections every 28 days for 13 doses as open-label therapy. Patients enter the study as 'roll-over' patients from study RB-US-09-0010, or de novo patients. Pre-study procedures vary for de novo patients depending on previous therapy.
intervention type: Drug
intervention name: RBP-7000
description: 120-mg RBP-7000 dose delivered by subcutaneous injection every 28 days for a total of 13 injections (for roll-over participants, the first two injections took place under study RB-US-09-0010).
A one-time down-titration to 90 mg RBP-7000 is permitted at the investigator's discretion should the participant have tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.
RBP-7000 is a combination of the ATRIGEL Delivery System and risperidone. The ATRIGEL Delivery System allows for sustained-release of risperidone in a controlled manner.
arm group label: RBP-7000 - 120-mg dose
other name: Risperidone
other name: Long-acting Risperidone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Indivior Inc.
role: Study Director
affiliation: Indivior Inc.
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country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Risperidone
sharing ipd: No
participant flow: 
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certain agreements: 
point of contact: 