<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/NCT01677377</url>
  </required_header>
  <id_info>
    <org_study_id>RB-US-09-0009</org_study_id>
    <nct_id>NCT01677377</nct_id>
  </id_info>
  <brief_title>Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic/Efficacy</brief_title>
  <official_title>A Phase 2A, Open-Label, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Primary Pharmacodynamic Markers of Efficacy of 60mg, 90mg, and 120mg of Risperidone in RBP-7000 Subcutaneous Injections in Subjects With Clinically Stable 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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the safety and tolerability of multiple subcutaneous injections of various dosages&#xD;
      of risperidone with clinically stable schizophrenia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be an open-label, Phase 2A, multiple ascending dose study in 1 to 3 sites, designed&#xD;
      to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple&#xD;
      subcutaneous injections of 60mg, 90mg, and 120mg doses of risperidone in the RBP-7000&#xD;
      formulation, in subjects with clinically-stable schizophrenia who are on a once daily stable&#xD;
      dose of 2mg, 3mg, or 4mg of oral risperidone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Summary of Participants With Treatment-Emergent Adverse Events (TEAE)</measure>
    <time_frame>Day 1 to Day 106</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>Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)</measure>
    <time_frame>Day 1-2, Day 57-58</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
AUC0-24 calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak</measure>
    <time_frame>Day 1-2, Day 57-58</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Cmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak</measure>
    <time_frame>Day 1-2, Day 57-58</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Tmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
AUCtau calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Percent Fluctuation Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Swing Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 at time of study drug administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Percent Fluctuation Over the Secondary Peak</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Swing Over the Secondary Peak</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)</measure>
    <time_frame>Day 1-2, Day 57-58</time_frame>
    <description>AUC0-24 calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak</measure>
    <time_frame>Day 1-2, Day 57-58</time_frame>
    <description>Cmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak</measure>
    <time_frame>Day 1-2, Day 57-58</time_frame>
    <description>Tmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>AUCtau calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Percent Fluctuation Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Swing Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Percent Fluctuation Over the Secondary Peak</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Swing Over the Secondary Peak</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)</measure>
    <time_frame>Day 1-2, Day 57-58</time_frame>
    <description>AUC0-24 calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak</measure>
    <time_frame>Day 1-2, Day 57-58</time_frame>
    <description>Cmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak</measure>
    <time_frame>Day 1-2, Day 57-58</time_frame>
    <description>Tmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>AUCtau calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Percent Fluctuation Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Swing Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))</measure>
    <time_frame>Day 1-28, Day 57-84</time_frame>
    <description>Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Percent Fluctuation Over the Secondary Peak</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Swing Over the Secondary Peak</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hydroxyrisperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak</measure>
    <time_frame>Day 2-29, Day 58-85</time_frame>
    <description>Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Syndrome Scale (PANSS) Scores at Baseline and Days 28, 56, 84 and 106</measure>
    <time_frame>Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)</time_frame>
    <description>The switch from oral risperidone to RBP-7000 subcutaneous injections for efficacy markers used the PANSS scores. The PANSS assessment is a medical scale designed to measure symptom severity among patients with schizophrenia. Each item is rated on a scale of 1=absent to 7=extreme. PANSS consists of three components:&#xD;
The General Psychopathology Scale consists of 16 questions with a total range of 16 (no schizophrenia symptoms) to 112 (extreme schizophrenia symptoms).&#xD;
Both the Positive Scale and the Negative Scale consists of 7 questions with a total range of 7 (no schizophrenia symptoms) to 49 (extreme symptoms) on each scale.&#xD;
The PANSS range for assuring stability was a total PANSS General Psychopathology Scale score of 70 or less, with no score of 4 on any of the 7 questions in the Positive scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression (CGI) Scores (Severity of Illness and Global Improvement) at Baseline and Days 28, 56, 84 and 106</measure>
    <time_frame>Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)</time_frame>
    <description>The switch from oral risperidone to RBP-7000 subcutaneous injections for efficacy markers used CGI scores. The CGI is used in the assessment of global illness severity and change in clinical condition over time in psychiatric patients.&#xD;
Severity of illness is measured on a 7-point scale with 1=normal, not at all ill and 7=among the most extremely ill patients.&#xD;
Global improvement is measured on a 7-point scale with 1=very much improved, 4=no change and 7=very much worse as compared to the severity of illness at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of the Abnormal Involuntary Movement Scale (AIMS) for Tardive Dyskinesia at Baseline and Days 28, 56, 84 and 106</measure>
    <time_frame>Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)</time_frame>
    <description>The switch from oral risperidone to RBP-7000 subcutaneous injections for safety markers used AIMS. The AIMS is a scale that aids in the early detection and ongoing monitoring of tardive dyskinesia, a movement disorder that can result from long-term treatment with antipsychotic medication. By assessing the participant's body movement in specific positions requiring rotation, a psychiatrist is able to determine whether abnormal facial or body movements exist.&#xD;
The total score is the sum of 7 questions assessing movement plus 3 questions representing global assessments on the overall level of involuntary movement severity, incapacitation due to involuntary movement, and patient's awareness of involuntary movement. Each of the 10 questions are scored on a 0 (none) - 4 (extremely severe) scale. Plus two dental status questions are scored on a 0 (no) - 1 (yes) scale. The total score is therefore a scale of 0 (normal) - 42 (advanced tardive dyskinesia).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Simpson-Angus Scale (SAS) Score at Baseline and Days 28, 56, 84 and 106</measure>
    <time_frame>Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)</time_frame>
    <description>The switch from oral risperidone to RBP-7000 subcutaneous injections for safety markers used SAS. The SAS is a 10-item scale used to detect the presence of drug induced parkinsonism and extrapyramidal side effects, and evaluates symptom severity. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0 to 4 scale with 0=normal and 4=extreme description of the particular side effect. The total range is 0=no side effects observed to 40 = extreme of each of the 10 side effects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Clinical Assessment of Akathisia Using the Barnes Akathisia Scale (BAS) at Baseline and Days 28, 56, 84 and 106</measure>
    <time_frame>Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)</time_frame>
    <description>The BAS is a scale that detects the presence and severity of any drug induced akathisia. The scale measures objective and subjective effects such as restlessness and awareness of restlessness, respectively. Participants are observed while seated, then while standing and engaged in neutral conversation. Symptoms observed during additional situations, such as participant behavior on the ward, may also be rated. Subjective phenomena should be elicited through direct questioning of the participant. The global clinical assessment is reported on a scale of 0 to 5, where 0 = absent and 5 = severe akathisia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants With Suicidal Ideation or Behavior as Identified Using the Columbia-Suicide Severity Rating Scale (C-SSRS) Score at Baseline and Days 28, 56, 84 and 106</measure>
    <time_frame>Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)</time_frame>
    <description>The C-SSRS is a scale developed by the National Institute of Mental Health trial group as a counterpart to the FDA's categorization of suicidal events. It was developed by a careful review and consequent categorization of thoughts and behavior that were statistically identified as significantly related to suicidal behavior. The scale captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors throughout lifetime at screening, baseline, and for the time interval since last administration for repeat administrations during a study.&#xD;
This outcome reports the number of participants with suicidal ideation or behavior.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Cohort 1, RBP-7000 60 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2, RBP-7000 90 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3, RBP-7000 120 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risperidone</intervention_name>
    <description>Oral risperidone was supplied as 2, 3, or 4 mg tablets in blister packs or bottles and taken daily only during the oral dosing periods of the study, days -14 through -8 (if applicable), days -7 through -1, and days 85 through 87.</description>
    <arm_group_label>Cohort 1, RBP-7000 60 mg</arm_group_label>
    <arm_group_label>Cohort 2, RBP-7000 90 mg</arm_group_label>
    <arm_group_label>Cohort 3, RBP-7000 120 mg</arm_group_label>
    <other_name>Risperdal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RBP-7000</intervention_name>
    <description>RBP-7000 60 mg, 90 mg, and 120 mg were a mixture of the ATRIGEL® Delivery System and 60 mg, 90 mg, or 120 mg risperidone, respectively. Treatment was delivered as subcutaneous injections on study days 1, 29 and 57.</description>
    <arm_group_label>Cohort 1, RBP-7000 60 mg</arm_group_label>
    <arm_group_label>Cohort 2, RBP-7000 90 mg</arm_group_label>
    <arm_group_label>Cohort 3, RBP-7000 120 mg</arm_group_label>
    <other_name>risperidone in Atrigel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female&#xD;
&#xD;
          -  &gt; 18 to &lt; 65 years&#xD;
&#xD;
          -  Diagnosis of paranoid, residual, or undifferentiated schizophrenia as defined by&#xD;
             Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR)&#xD;
             criteria&#xD;
&#xD;
               -  Status: clinically stable subjects defined as subjects with no hospitalizations&#xD;
                  for acute exacerbations within 3 months of screening and screening total Positive&#xD;
                  and Negative Syndrome Scale (PANSS) score &lt; 60&#xD;
&#xD;
          -  Subjects who have given written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects taking any risperidone sustained release formulation within the 60 days prior&#xD;
             to study screening&#xD;
&#xD;
          -  Subjects taking the following concurrent medication/over-the-counter products:&#xD;
&#xD;
          -  Inducers or inhibitors of cytochrome P450 2D6 (CYP-2D6) within 14 days or 7 half -&#xD;
             lives (whichever occurs last) prior to study screening&#xD;
&#xD;
          -  Bupropion, chlorpheniramine, cimetidine, clomipramine, doxepin, or quinidine within 30&#xD;
             days prior to study screening&#xD;
&#xD;
          -  Clozapine, phenothiazines, aripiprazole, haloperidol, or any other antipsychotic other&#xD;
             than oral risperidone within 14 days prior to study screening&#xD;
&#xD;
          -  Selective serotonin reuptake inhibitors (e.g., fluoxetine, paroxetine) or&#xD;
             serotonin-norepinephrine reuptake inhibitors (e.g., venlafaxine, desvenlafaxine,&#xD;
             duloxetine) within 30 days prior to study screening&#xD;
&#xD;
          -  Opioids or opioid-containing analgesics within 14 days prior to study screening&#xD;
&#xD;
          -  Medications, in addition to those listed above, which may be expected to significantly&#xD;
             interfere with the metabolism or excretion of risperidone and/or 9-hydroxyrisperidone,&#xD;
             that may be associated with a significant drug interaction with risperidone, or that&#xD;
             may pose a significant risk to subjects' participation in the study&#xD;
&#xD;
          -  Subjects with a history of cancer (with the exception of resected basal cell or&#xD;
             squamous cell carcinoma of the skin) unless they have been disease free for &gt;5 years&#xD;
&#xD;
          -  Subjects with another active medical condition or organ disease that may either&#xD;
             compromise subject safety and/or outcome evaluation of the study drug&#xD;
&#xD;
          -  Subjects with evidence or history of a significant hepatic disorder that may either&#xD;
             compromise subject safety or interfere with the safety and/or outcome evaluation of&#xD;
             the study drug. Individuals with acute hepatitis (including but not limited to B or&#xD;
             C); or individuals with 1) total bilirubin &gt;1.5x the upper limit of normal and/or 2)&#xD;
             alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;2x upper limit of&#xD;
             normal (ULN) will be excluded&#xD;
&#xD;
          -  Subjects with hepatitis C antibody and AST, ALT, or alkaline phosphatase &gt;2x and total&#xD;
             bilirubin &gt;1.3 mg/dL will be excluded&#xD;
&#xD;
          -  Subjects with a history of renal disease, or a creatinine clearance of less than 80&#xD;
             mL/min (as determined by the Cockcroft Gault formula)&#xD;
&#xD;
          -  Subjects with an international normalized ratio &gt;2.0 at screening&#xD;
&#xD;
          -  Subjects with corrected QT interval (Bazett's - QTcB) &gt;450 msec (male) or &gt;470 msec&#xD;
             (female) at screening. Subjects with a QTc above these levels due to a benign right&#xD;
             bundle branch block can be included in the study at the discretion of the PI&#xD;
&#xD;
          -  Subjects who are known to have AIDS or to be HIV positive&#xD;
&#xD;
          -  Subjects with suicidal ideation with intent and plan (Columbia-Suicide Severity Rating&#xD;
             Scale (C-SSRS) affirmative answers to questions 4 and 5 of the ideation section) or&#xD;
             suicide attempts within the last six months as noted on the C-SSRS, or subjects with&#xD;
             uncontrolled depression in the opinion of the investigator&#xD;
&#xD;
          -  Subjects with known diagnosis of type 1 or 2 diabetes or subjects with Hemoglobin A1c&#xD;
             &gt;7.0 at screening&#xD;
&#xD;
          -  Subjects who have participated in a clinical trial within 30 days prior to study&#xD;
             screening&#xD;
&#xD;
          -  Subjects who meet the DSM-IV-TR criteria for alcohol abuse or dependence within the&#xD;
             last six months of screening&#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>Philippa Whitelaw, Sr. Dir of Proj Deliver</last_name>
    <role>Study Director</role>
    <affiliation>Pharmaceutical Research Associates</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ashley Huston, PMP</last_name>
    <role>Study Director</role>
    <affiliation>Pharmaceutical Research Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Woodland International Research Group, Inc.</name>
      <address>
        <city>Little Rock</city>
        <state>Alaska</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocean View Psychiatric Health Facility</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <results_first_submitted>August 31, 2018</results_first_submitted>
  <results_first_submitted_qc>October 22, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 23, 2018</results_first_posted>
  <disposition_first_submitted>August 7, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>August 7, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">August 24, 2015</disposition_first_posted>
  <last_update_submitted>October 22, 2018</last_update_submitted>
  <last_update_submitted_qc>October 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Schizophrenic</keyword>
  <keyword>Schizophrenias</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>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This was an open-label, Phase 2A, multiple-ascending dose study performed at 2 sites in the U.S. Seventy subjects were screened and 45 subjects were enrolled and received RBP-7000.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1, RBP-7000 60 mg</title>
          <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2, RBP-7000 90 mg</title>
          <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
        </group>
        <group group_id="P3">
          <title>Cohort 3, RBP-7000 120 mg</title>
          <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1, RBP-7000 60 mg</title>
          <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2, RBP-7000 90 mg</title>
          <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
        </group>
        <group group_id="B3">
          <title>Cohort 3, RBP-7000 120 mg</title>
          <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="15"/>
            <count group_id="B4" value="45"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.7" spread="9.98"/>
                    <measurement group_id="B2" value="42.5" spread="9.93"/>
                    <measurement group_id="B3" value="41.7" spread="7.96"/>
                    <measurement group_id="B4" value="42.6" spread="9.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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="1"/>
                    <measurement group_id="B4" value="2"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83.76" spread="16.279"/>
                    <measurement group_id="B2" value="84.07" spread="13.707"/>
                    <measurement group_id="B3" value="92.63" spread="14.075"/>
                    <measurement group_id="B4" value="86.82" spread="14.980"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="172.19" spread="8.731"/>
                    <measurement group_id="B2" value="175.50" spread="11.137"/>
                    <measurement group_id="B3" value="174.41" spread="8.346"/>
                    <measurement group_id="B4" value="174.03" spread="9.372"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.13" spread="4.487"/>
                    <measurement group_id="B2" value="27.35" spread="4.176"/>
                    <measurement group_id="B3" value="30.43" spread="3.911"/>
                    <measurement group_id="B4" value="28.64" spread="4.309"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cytochrome P450 2D6 (CYP-2D6)</title>
          <description>CYP-2D6 is an enzyme responsible for the metabolism and elimination of many drugs. Considerable variation exists in the efficiency and amount of CYP-2D6 enzyme produced between individuals. Hence, for drugs that are metabolized by CYP-2D6, certain individuals will eliminate these drugs quickly (ultrarapid metabolizers) while others slowly (poor metabolizers).&#xD;
poor metabolizer - little or no CYP-2D6 function&#xD;
intermediate metabolizers - metabolize drugs at a rate somewhere between the poor and extensive metabolizers&#xD;
extensive metabolizer - normal CYP-2D6 function</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Intermediate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Poor</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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extensive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Summary of 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 to Day 106</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of 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</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="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 or more TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAEs</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious, 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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE causing discontinuation</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death</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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
AUC0-24 calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-2, Day 57-58</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
AUC0-24 calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hr*ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Initial Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="335.4" lower_limit="178.4" upper_limit="874.4"/>
                    <measurement group_id="O2" value="437.5" lower_limit="203.2" upper_limit="942.3"/>
                    <measurement group_id="O3" value="466.2" lower_limit="193.6" upper_limit="872.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Initial Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="276.5" lower_limit="113.3" upper_limit="821.6"/>
                    <measurement group_id="O2" value="415.1" lower_limit="151.4" upper_limit="697.0"/>
                    <measurement group_id="O3" value="497.5" lower_limit="304.9" upper_limit="788.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Cmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-2, Day 57-58</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Cmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Initial Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.343" lower_limit="8.49" upper_limit="45.33"/>
                    <measurement group_id="O2" value="19.415" lower_limit="9.88" upper_limit="41.14"/>
                    <measurement group_id="O3" value="24.400" lower_limit="9.00" upper_limit="42.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Initial Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.549" lower_limit="5.71" upper_limit="37.66"/>
                    <measurement group_id="O2" value="16.973" lower_limit="7.06" upper_limit="39.44"/>
                    <measurement group_id="O3" value="22.852" lower_limit="13.35" upper_limit="39.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Tmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-2, Day 57-58</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Tmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Initial Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.000" lower_limit="3.00" upper_limit="23.83"/>
                    <measurement group_id="O2" value="6.000" lower_limit="2.00" upper_limit="12.02"/>
                    <measurement group_id="O3" value="6.000" lower_limit="2.00" upper_limit="24.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Initial Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.917" lower_limit="6.00" upper_limit="24.00"/>
                    <measurement group_id="O2" value="24.000" lower_limit="3.00" upper_limit="24.08"/>
                    <measurement group_id="O3" value="24.000" lower_limit="6.00" upper_limit="24.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
AUCtau calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
AUCtau calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hr*ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6506.0" lower_limit="2400.2" upper_limit="16817.9"/>
                    <measurement group_id="O2" value="8293.8" lower_limit="3680.3" upper_limit="19454.6"/>
                    <measurement group_id="O3" value="12594.7" lower_limit="7894.8" upper_limit="17498.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8567.1" lower_limit="3890.3" upper_limit="17097.5"/>
                    <measurement group_id="O2" value="11047.7" lower_limit="7197.5" upper_limit="22067.1"/>
                    <measurement group_id="O3" value="15982.6" lower_limit="10256.6" upper_limit="18661.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.682" lower_limit="3.57" upper_limit="25.03"/>
                    <measurement group_id="O2" value="12.342" lower_limit="5.48" upper_limit="28.95"/>
                    <measurement group_id="O3" value="18.742" lower_limit="11.75" upper_limit="26.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.749" lower_limit="5.79" upper_limit="25.44"/>
                    <measurement group_id="O2" value="16.440" lower_limit="10.71" upper_limit="32.84"/>
                    <measurement group_id="O3" value="23.784" lower_limit="15.26" upper_limit="27.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.878" lower_limit="9.35" upper_limit="57.61"/>
                    <measurement group_id="O2" value="22.825" lower_limit="10.89" upper_limit="41.14"/>
                    <measurement group_id="O3" value="32.235" lower_limit="19.53" upper_limit="55.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.885" lower_limit="8.56" upper_limit="42.11"/>
                    <measurement group_id="O2" value="30.804" lower_limit="16.64" upper_limit="55.63"/>
                    <measurement group_id="O3" value="38.300" lower_limit="23.76" upper_limit="53.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.867" lower_limit="1.88" upper_limit="13.54"/>
                    <measurement group_id="O2" value="5.642" lower_limit="2.63" upper_limit="20.31"/>
                    <measurement group_id="O3" value="9.159" lower_limit="3.28" upper_limit="15.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.028" lower_limit="1.79" upper_limit="11.64"/>
                    <measurement group_id="O2" value="10.534" lower_limit="3.85" upper_limit="14.80"/>
                    <measurement group_id="O3" value="11.938" lower_limit="6.56" upper_limit="14.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Percent Fluctuation Over the PK Profile</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Percent Fluctuation Over the PK Profile</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>percentage of average concentration</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151.211" lower_limit="69.88" upper_limit="371.07"/>
                    <measurement group_id="O2" value="135.238" lower_limit="71.94" upper_limit="217.01"/>
                    <measurement group_id="O3" value="153.386" lower_limit="64.60" upper_limit="179.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.226" lower_limit="59.48" upper_limit="185.63"/>
                    <measurement group_id="O2" value="102.396" lower_limit="57.34" upper_limit="162.19"/>
                    <measurement group_id="O3" value="114.008" lower_limit="86.28" upper_limit="181.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Swing Over the PK Profile</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Swing Over the PK Profile</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.502" lower_limit="1.02" upper_limit="12.44"/>
                    <measurement group_id="O2" value="2.150" lower_limit="1.03" upper_limit="5.39"/>
                    <measurement group_id="O3" value="2.928" lower_limit="0.98" upper_limit="8.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.588" lower_limit="0.90" upper_limit="7.48"/>
                    <measurement group_id="O2" value="2.052" lower_limit="0.74" upper_limit="4.29"/>
                    <measurement group_id="O3" value="2.019" lower_limit="1.47" upper_limit="6.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168.000" lower_limit="4.00" upper_limit="504.00"/>
                    <measurement group_id="O2" value="215.833" lower_limit="4.00" upper_limit="579.02"/>
                    <measurement group_id="O3" value="192.000" lower_limit="6.00" upper_limit="574.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="216.00" lower_limit="12.00" upper_limit="408.00"/>
                    <measurement group_id="O2" value="264.067" lower_limit="24.00" upper_limit="408.00"/>
                    <measurement group_id="O3" value="216.000" lower_limit="168.00" upper_limit="504.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.8" upper_limit="2.9"/>
                    <measurement group_id="O2" value="1.6" lower_limit="1.0" upper_limit="2.9"/>
                    <measurement group_id="O3" value="1.2" lower_limit="1.0" upper_limit="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.976" lower_limit="0.62" upper_limit="2.21"/>
                    <measurement group_id="O2" value="1.525" lower_limit="0.73" upper_limit="2.83"/>
                    <measurement group_id="O3" value="1.105" lower_limit="0.81" upper_limit="2.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 at time of study drug administration.</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 at time of study drug administration.</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hr*ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6186.9" lower_limit="2219.4" upper_limit="16241.8"/>
                    <measurement group_id="O2" value="7735.1" lower_limit="3458.0" upper_limit="18517.4"/>
                    <measurement group_id="O3" value="10001.4" lower_limit="5973.7" upper_limit="16936.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8236.4" lower_limit="3726.5" upper_limit="16278.8"/>
                    <measurement group_id="O2" value="10988.6" lower_limit="7047.1" upper_limit="21379.3"/>
                    <measurement group_id="O3" value="15484.3" lower_limit="9954.0" upper_limit="17931.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.548" lower_limit="3.42" upper_limit="25.06"/>
                    <measurement group_id="O2" value="11.937" lower_limit="5.34" upper_limit="28.58"/>
                    <measurement group_id="O3" value="15.434" lower_limit="9.22" upper_limit="26.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.710" lower_limit="5.75" upper_limit="25.12"/>
                    <measurement group_id="O2" value="16.958" lower_limit="10.88" upper_limit="32.99"/>
                    <measurement group_id="O3" value="23.896" lower_limit="15.36" upper_limit="27.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.867" lower_limit="6.42" upper_limit="57.61"/>
                    <measurement group_id="O2" value="21.415" lower_limit="9.26" upper_limit="41.06"/>
                    <measurement group_id="O3" value="32.235" lower_limit="19.53" upper_limit="55.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.885" lower_limit="8.56" upper_limit="42.11"/>
                    <measurement group_id="O2" value="30.804" lower_limit="16.64" upper_limit="55.63"/>
                    <measurement group_id="O3" value="38.300" lower_limit="23.76" upper_limit="53.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.867" lower_limit="1.88" upper_limit="13.54"/>
                    <measurement group_id="O2" value="5.642" lower_limit="2.63" upper_limit="20.31"/>
                    <measurement group_id="O3" value="9.159" lower_limit="3.28" upper_limit="15.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.028" lower_limit="1.79" upper_limit="13.33"/>
                    <measurement group_id="O2" value="10.534" lower_limit="3.85" upper_limit="18.26"/>
                    <measurement group_id="O3" value="13.735" lower_limit="8.47" upper_limit="21.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Percent Fluctuation Over the Secondary Peak</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Percent Fluctuation Over the Secondary Peak</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>percentage of average concentration</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122.350" lower_limit="70.17" upper_limit="246.65"/>
                    <measurement group_id="O2" value="122.042" lower_limit="72.60" upper_limit="204.59"/>
                    <measurement group_id="O3" value="151.294" lower_limit="76.81" upper_limit="187.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.788" lower_limit="59.50" upper_limit="183.28"/>
                    <measurement group_id="O2" value="101.666" lower_limit="55.92" upper_limit="162.53"/>
                    <measurement group_id="O3" value="96.489" lower_limit="80.33" upper_limit="162.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Swing Over the Secondary Peak</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Swing Over the Secondary Peak</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.048" lower_limit="1.02" upper_limit="12.44"/>
                    <measurement group_id="O2" value="2.017" lower_limit="1.02" upper_limit="5.39"/>
                    <measurement group_id="O3" value="2.928" lower_limit="0.98" upper_limit="5.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.412" lower_limit="0.90" upper_limit="7.48"/>
                    <measurement group_id="O2" value="1.914" lower_limit="0.72" upper_limit="3.91"/>
                    <measurement group_id="O3" value="1.679" lower_limit="1.15" upper_limit="5.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak</title>
        <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak</title>
          <description>Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:&#xD;
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168.000" lower_limit="23.83" upper_limit="504.00"/>
                    <measurement group_id="O2" value="264.000" lower_limit="24.00" upper_limit="579.02"/>
                    <measurement group_id="O3" value="192.000" lower_limit="24.00" upper_limit="574.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="228.000" lower_limit="23.83" upper_limit="408.00"/>
                    <measurement group_id="O2" value="264.067" lower_limit="24.00" upper_limit="408.00"/>
                    <measurement group_id="O3" value="216.000" lower_limit="168.00" upper_limit="504.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)</title>
        <description>AUC0-24 calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-2, Day 57-58</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)</title>
          <description>AUC0-24 calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hr*ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Initial Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103.8" lower_limit="19.7" upper_limit="482.2"/>
                    <measurement group_id="O2" value="87.8" lower_limit="30.0" upper_limit="367.9"/>
                    <measurement group_id="O3" value="99.5" lower_limit="46.9" upper_limit="329.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Initial Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.7" lower_limit="35.1" upper_limit="557.9"/>
                    <measurement group_id="O2" value="107.1" lower_limit="61.2" upper_limit="554.5"/>
                    <measurement group_id="O3" value="127.0" lower_limit="82.1" upper_limit="329.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak</title>
        <description>Cmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-2, Day 57-58</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak</title>
          <description>Cmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Initial Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.280" lower_limit="1.32" upper_limit="25.70"/>
                    <measurement group_id="O2" value="5.460" lower_limit="1.75" upper_limit="16.80"/>
                    <measurement group_id="O3" value="6.470" lower_limit="2.80" upper_limit="15.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Initial Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.955" lower_limit="1.98" upper_limit="26.30"/>
                    <measurement group_id="O2" value="6.680" lower_limit="2.89" upper_limit="30.60"/>
                    <measurement group_id="O3" value="7.145" lower_limit="4.27" upper_limit="18.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak</title>
        <description>Tmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-2, Day 57-58</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak</title>
          <description>Tmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Initial Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.000" lower_limit="3.00" upper_limit="23.83"/>
                    <measurement group_id="O2" value="6.000" lower_limit="2.00" upper_limit="6.02"/>
                    <measurement group_id="O3" value="4.000" lower_limit="1.00" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Initial Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.000" lower_limit="2.00" upper_limit="24.00"/>
                    <measurement group_id="O2" value="6.000" lower_limit="3.00" upper_limit="24.08"/>
                    <measurement group_id="O3" value="4.483" lower_limit="2.00" upper_limit="24.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)</title>
        <description>AUCtau calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)</title>
          <description>AUCtau calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hr*ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1250.9" lower_limit="403.7" upper_limit="8706.0"/>
                    <measurement group_id="O2" value="1663.4" lower_limit="764.3" upper_limit="10010.9"/>
                    <measurement group_id="O3" value="3099.4" lower_limit="1768.5" upper_limit="7202.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2144.6" lower_limit="741.2" upper_limit="10490.3"/>
                    <measurement group_id="O2" value="2647.1" lower_limit="1683.5" upper_limit="15384.8"/>
                    <measurement group_id="O3" value="3621.2" lower_limit="2084.2" upper_limit="7812.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile</title>
        <description>The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile</title>
          <description>The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.861" lower_limit="0.60" upper_limit="12.96"/>
                    <measurement group_id="O2" value="2.475" lower_limit="1.14" upper_limit="14.90"/>
                    <measurement group_id="O3" value="4.612" lower_limit="2.63" upper_limit="10.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.191" lower_limit="1.10" upper_limit="15.61"/>
                    <measurement group_id="O2" value="3.939" lower_limit="2.51" upper_limit="22.89"/>
                    <measurement group_id="O3" value="5.389" lower_limit="3.10" upper_limit="11.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile</title>
        <description>Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile</title>
          <description>Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.280" lower_limit="1.32" upper_limit="37.40"/>
                    <measurement group_id="O2" value="7.520" lower_limit="2.01" upper_limit="24.40"/>
                    <measurement group_id="O3" value="9.270" lower_limit="4.27" upper_limit="18.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.720" lower_limit="2.00" upper_limit="26.30"/>
                    <measurement group_id="O2" value="7.490" lower_limit="4.23" upper_limit="38.40"/>
                    <measurement group_id="O3" value="12.125" lower_limit="5.00" upper_limit="21.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile</title>
        <description>Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile</title>
          <description>Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.829" lower_limit="0.25" upper_limit="4.81"/>
                    <measurement group_id="O2" value="1.060" lower_limit="0.42" upper_limit="9.44"/>
                    <measurement group_id="O3" value="1.720" lower_limit="0.59" upper_limit="6.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.230" lower_limit="0.39" upper_limit="4.24"/>
                    <measurement group_id="O2" value="2.100" lower_limit="0.85" upper_limit="12.30"/>
                    <measurement group_id="O3" value="2.415" lower_limit="1.24" upper_limit="4.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Percent Fluctuation Over the PK Profile</title>
        <description>The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Percent Fluctuation Over the PK Profile</title>
          <description>The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>percentage of average concentration</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="190.745" lower_limit="97.90" upper_limit="914.27"/>
                    <measurement group_id="O2" value="215.048" lower_limit="100.42" upper_limit="423.52"/>
                    <measurement group_id="O3" value="173.609" lower_limit="80.43" upper_limit="258.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147.252" lower_limit="75.60" upper_limit="212.01"/>
                    <measurement group_id="O2" value="140.688" lower_limit="55.32" upper_limit="343.98"/>
                    <measurement group_id="O3" value="143.652" lower_limit="93.11" upper_limit="206.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Swing Over the PK Profile</title>
        <description>The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Swing Over the PK Profile</title>
          <description>The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.575" lower_limit="1.58" upper_limit="34.19"/>
                    <measurement group_id="O2" value="4.151" lower_limit="1.58" upper_limit="32.57"/>
                    <measurement group_id="O3" value="4.938" lower_limit="1.33" upper_limit="12.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.077" lower_limit="1.19" upper_limit="6.09"/>
                    <measurement group_id="O2" value="2.863" lower_limit="0.77" upper_limit="10.56"/>
                    <measurement group_id="O3" value="3.159" lower_limit="1.78" upper_limit="8.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile</title>
        <description>Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile</title>
          <description>Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.000" lower_limit="4.00" upper_limit="408.28"/>
                    <measurement group_id="O2" value="168.000" lower_limit="3.00" upper_limit="336.00"/>
                    <measurement group_id="O3" value="192.000" lower_limit="3.00" upper_limit="384.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.000" lower_limit="2.00" upper_limit="408.00"/>
                    <measurement group_id="O2" value="192.000" lower_limit="3.00" upper_limit="671.75"/>
                    <measurement group_id="O3" value="180.000" lower_limit="72.00" upper_limit="504.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))</title>
        <description>Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))</title>
          <description>Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.6" upper_limit="4.8"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.0" upper_limit="3.2"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.0" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))</title>
        <description>Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))</title>
          <description>Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.049" lower_limit="0.20" upper_limit="2.16"/>
                    <measurement group_id="O2" value="1.214" lower_limit="0.54" upper_limit="2.85"/>
                    <measurement group_id="O3" value="1.155" lower_limit="0.62" upper_limit="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)</title>
        <description>Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)</title>
          <description>Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hr*ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1198.2" lower_limit="384.0" upper_limit="8450.7"/>
                    <measurement group_id="O2" value="1544.9" lower_limit="730.6" upper_limit="9645.4"/>
                    <measurement group_id="O3" value="2937.3" lower_limit="1133.1" upper_limit="6919.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2204.6" lower_limit="836.0" upper_limit="9933.4"/>
                    <measurement group_id="O2" value="2494.8" lower_limit="1621.8" upper_limit="14833.4"/>
                    <measurement group_id="O3" value="3476.6" lower_limit="1996.8" upper_limit="7597.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)</title>
        <description>The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)</title>
          <description>The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.849" lower_limit="0.59" upper_limit="13.04"/>
                    <measurement group_id="O2" value="2.384" lower_limit="1.13" upper_limit="14.88"/>
                    <measurement group_id="O3" value="4.533" lower_limit="1.75" upper_limit="10.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.402" lower_limit="1.29" upper_limit="15.33"/>
                    <measurement group_id="O2" value="3.850" lower_limit="2.50" upper_limit="22.89"/>
                    <measurement group_id="O3" value="5.365" lower_limit="3.08" upper_limit="11.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)</title>
        <description>Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)</title>
          <description>Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.120" lower_limit="0.76" upper_limit="37.40"/>
                    <measurement group_id="O2" value="5.950" lower_limit="2.01" upper_limit="24.40"/>
                    <measurement group_id="O3" value="7.950" lower_limit="2.98" upper_limit="18.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.220" lower_limit="1.46" upper_limit="25.50"/>
                    <measurement group_id="O2" value="7.010" lower_limit="4.23" upper_limit="38.40"/>
                    <measurement group_id="O3" value="12.125" lower_limit="5.09" upper_limit="21.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak</title>
        <description>Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak</title>
          <description>Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.829" lower_limit="0.25" upper_limit="4.81"/>
                    <measurement group_id="O2" value="1.070" lower_limit="0.56" upper_limit="9.44"/>
                    <measurement group_id="O3" value="1.720" lower_limit="0.59" upper_limit="6.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.230" lower_limit="0.39" upper_limit="5.31"/>
                    <measurement group_id="O2" value="2.100" lower_limit="0.85" upper_limit="12.30"/>
                    <measurement group_id="O3" value="2.415" lower_limit="1.24" upper_limit="8.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Percent Fluctuation Over the Secondary Peak</title>
        <description>The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Percent Fluctuation Over the Secondary Peak</title>
          <description>The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>percentage of average concentration</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134.805" lower_limit="53.99" upper_limit="288.36"/>
                    <measurement group_id="O2" value="134.898" lower_limit="68.79" upper_limit="274.33"/>
                    <measurement group_id="O3" value="141.030" lower_limit="80.73" upper_limit="239.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136.691" lower_limit="75.83" upper_limit="211.81"/>
                    <measurement group_id="O2" value="125.387" lower_limit="55.36" upper_limit="345.51"/>
                    <measurement group_id="O3" value="138.380" lower_limit="93.02" upper_limit="207.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Swing Over the Secondary Peak</title>
        <description>The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Swing Over the Secondary Peak</title>
          <description>The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.644" lower_limit="0.74" upper_limit="16.05"/>
                    <measurement group_id="O2" value="2.680" lower_limit="0.94" upper_limit="8.52"/>
                    <measurement group_id="O3" value="3.813" lower_limit="1.33" upper_limit="6.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.736" lower_limit="1.09" upper_limit="6.09"/>
                    <measurement group_id="O2" value="2.652" lower_limit="0.77" upper_limit="10.56"/>
                    <measurement group_id="O3" value="2.698" lower_limit="1.52" upper_limit="8.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak</title>
        <description>Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak</title>
          <description>Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120.000" lower_limit="23.83" upper_limit="408.28"/>
                    <measurement group_id="O2" value="216.000" lower_limit="24.02" upper_limit="336.00"/>
                    <measurement group_id="O3" value="192.000" lower_limit="24.00" upper_limit="385.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="204.000" lower_limit="23.83" upper_limit="576.00"/>
                    <measurement group_id="O2" value="216.00" lower_limit="24.00" upper_limit="671.75"/>
                    <measurement group_id="O3" value="180.000" lower_limit="72.00" upper_limit="504.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)</title>
        <description>AUC0-24 calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-2, Day 57-58</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)</title>
          <description>AUC0-24 calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hr*ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Initial Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="237.0" lower_limit="149.4" upper_limit="407.6"/>
                    <measurement group_id="O2" value="251.1" lower_limit="84.4" upper_limit="855.4"/>
                    <measurement group_id="O3" value="404.8" lower_limit="152.4" upper_limit="715.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Initial Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169.2" lower_limit="76.6" upper_limit="291.0"/>
                    <measurement group_id="O2" value="263.4" lower_limit="93.7" upper_limit="514.4"/>
                    <measurement group_id="O3" value="342.6" lower_limit="231.4" upper_limit="477.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak</title>
        <description>Cmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-2, Day 57-58</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak</title>
          <description>Cmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Initial Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.100" lower_limit="6.64" upper_limit="24.30"/>
                    <measurement group_id="O2" value="12.900" lower_limit="4.17" upper_limit="37.80"/>
                    <measurement group_id="O3" value="17.500" lower_limit="7.32" upper_limit="33.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Initial Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.470" lower_limit="4.64" upper_limit="15.10"/>
                    <measurement group_id="O2" value="12.900" lower_limit="4.73" upper_limit="27.10"/>
                    <measurement group_id="O3" value="17.450" lower_limit="10.60" upper_limit="27.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak</title>
        <description>Tmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-2, Day 57-58</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak</title>
          <description>Tmax determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)&#xD;
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Initial Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.000" lower_limit="0.00" upper_limit="24.00"/>
                    <measurement group_id="O2" value="6.000" lower_limit="0.00" upper_limit="24.02"/>
                    <measurement group_id="O3" value="6.000" lower_limit="0.00" upper_limit="24.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Initial Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.000" lower_limit="0.00" upper_limit="24.00"/>
                    <measurement group_id="O2" value="24.000" lower_limit="23.83" upper_limit="24.08"/>
                    <measurement group_id="O3" value="24.000" lower_limit="23.85" upper_limit="24.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)</title>
        <description>AUCtau calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)</title>
          <description>AUCtau calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hr*ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4927.0" lower_limit="2074.5" upper_limit="8428.4"/>
                    <measurement group_id="O2" value="5607.5" lower_limit="1788.4" upper_limit="18485.5"/>
                    <measurement group_id="O3" value="9862.2" lower_limit="6172.8" upper_limit="12526.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5538.3" lower_limit="2877.4" upper_limit="11191.6"/>
                    <measurement group_id="O2" value="8546.7" lower_limit="3039.2" upper_limit="14534.1"/>
                    <measurement group_id="O3" value="11666.9" lower_limit="8212.3" upper_limit="14354.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile</title>
        <description>The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile</title>
          <description>The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.332" lower_limit="3.09" upper_limit="12.54"/>
                    <measurement group_id="O2" value="8.344" lower_limit="2.66" upper_limit="27.51"/>
                    <measurement group_id="O3" value="14.676" lower_limit="9.19" upper_limit="18.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.242" lower_limit="4.28" upper_limit="16.65"/>
                    <measurement group_id="O2" value="12.718" lower_limit="4.52" upper_limit="21.63"/>
                    <measurement group_id="O3" value="17.361" lower_limit="12.22" upper_limit="21.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile</title>
        <description>Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile</title>
          <description>Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.300" lower_limit="8.48" upper_limit="24.30"/>
                    <measurement group_id="O2" value="15.600" lower_limit="4.17" upper_limit="39.20"/>
                    <measurement group_id="O3" value="22.400" lower_limit="15.60" upper_limit="40.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.450" lower_limit="6.34" upper_limit="32.40"/>
                    <measurement group_id="O2" value="21.200" lower_limit="7.30" upper_limit="34.70"/>
                    <measurement group_id="O3" value="29.600" lower_limit="19.40" upper_limit="37.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile</title>
        <description>Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile</title>
          <description>Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.940" lower_limit="1.40" upper_limit="9.28"/>
                    <measurement group_id="O2" value="4.240" lower_limit="2.14" upper_limit="19.10"/>
                    <measurement group_id="O3" value="6.690" lower_limit="2.75" upper_limit="11.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.180" lower_limit="1.29" upper_limit="8.11"/>
                    <measurement group_id="O2" value="6.580" lower_limit="2.41" upper_limit="11.60"/>
                    <measurement group_id="O3" value="8.365" lower_limit="3.60" upper_limit="12.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Percent Fluctuation Over the PK Profile</title>
        <description>The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Percent Fluctuation Over the PK Profile</title>
          <description>The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>percentage of average concentration</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120.024" lower_limit="66.15" upper_limit="313.00"/>
                    <measurement group_id="O2" value="124.696" lower_limit="73.07" upper_limit="193.81"/>
                    <measurement group_id="O3" value="142.828" lower_limit="66.46" upper_limit="178.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121.077" lower_limit="47.08" upper_limit="195.10"/>
                    <measurement group_id="O2" value="106.728" lower_limit="80.34" upper_limit="174.90"/>
                    <measurement group_id="O3" value="122.701" lower_limit="79.58" upper_limit="172.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Swing Over the PK Profile</title>
        <description>The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Swing Over the PK Profile</title>
          <description>The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.984" lower_limit="0.99" upper_limit="12.11"/>
                    <measurement group_id="O2" value="2.041" lower_limit="0.89" upper_limit="5.72"/>
                    <measurement group_id="O3" value="2.633" lower_limit="0.96" upper_limit="8.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.901" lower_limit="0.63" upper_limit="8.24"/>
                    <measurement group_id="O2" value="2.142" lower_limit="1.28" upper_limit="6.51"/>
                    <measurement group_id="O3" value="2.240" lower_limit="1.36" upper_limit="7.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile</title>
        <description>Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile</title>
          <description>Results are reported across two timeframes:&#xD;
Overall, Injection 1 (Day 1 injection to Day 28)&#xD;
Overall, Injection 3 (Day 57 injection to Day 84)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168.000" lower_limit="0.00" upper_limit="504.00"/>
                    <measurement group_id="O2" value="168.000" lower_limit="0.00" upper_limit="579.02"/>
                    <measurement group_id="O3" value="192.000" lower_limit="0.00" upper_limit="574.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="216.000" lower_limit="1.00" upper_limit="408.00"/>
                    <measurement group_id="O2" value="264.000" lower_limit="24.00" upper_limit="336.00"/>
                    <measurement group_id="O3" value="216.000" lower_limit="168.00" upper_limit="552.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))</title>
        <description>Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))</title>
          <description>Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.8" upper_limit="2.1"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.0" upper_limit="2.8"/>
                    <measurement group_id="O3" value="1.2" lower_limit="1.0" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))</title>
        <description>Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 1-28, Day 57-84</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))</title>
          <description>Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.997" lower_limit="0.51" upper_limit="2.20"/>
                    <measurement group_id="O2" value="1.442" lower_limit="0.74" upper_limit="2.51"/>
                    <measurement group_id="O3" value="1.076" lower_limit="0.89" upper_limit="2.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)</title>
        <description>Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)</title>
          <description>Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hr*ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4696.8" lower_limit="1906.9" upper_limit="8095.4"/>
                    <measurement group_id="O2" value="5222.9" lower_limit="1704.6" upper_limit="17634.8"/>
                    <measurement group_id="O3" value="7891.0" lower_limit="5039.4" upper_limit="12116.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5388.2" lower_limit="2775.2" upper_limit="10973.2"/>
                    <measurement group_id="O2" value="8311.7" lower_limit="2943.9" upper_limit="14239.6"/>
                    <measurement group_id="O3" value="11786.5" lower_limit="7982.8" upper_limit="13933.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)</title>
        <description>The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)</title>
          <description>The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.248" lower_limit="2.94" upper_limit="12.49"/>
                    <measurement group_id="O2" value="8.060" lower_limit="2.63" upper_limit="27.21"/>
                    <measurement group_id="O3" value="12.177" lower_limit="7.78" upper_limit="18.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.315" lower_limit="4.28" upper_limit="16.93"/>
                    <measurement group_id="O2" value="12.827" lower_limit="4.54" upper_limit="21.97"/>
                    <measurement group_id="O3" value="18.189" lower_limit="12.32" upper_limit="21.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)</title>
        <description>Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)</title>
          <description>Maximum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.300" lower_limit="6.15" upper_limit="21.50"/>
                    <measurement group_id="O2" value="15.600" lower_limit="3.45" upper_limit="39.20"/>
                    <measurement group_id="O3" value="22.300" lower_limit="15.60" upper_limit="40.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.450" lower_limit="6.34" upper_limit="32.40"/>
                    <measurement group_id="O2" value="21.200" lower_limit="7.30" upper_limit="34.70"/>
                    <measurement group_id="O3" value="29.600" lower_limit="19.40" upper_limit="37.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak</title>
        <description>Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak</title>
          <description>Minimum plasma concentrations determined directly from individual concentration-time data.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.940" lower_limit="1.40" upper_limit="9.28"/>
                    <measurement group_id="O2" value="4.250" lower_limit="2.14" upper_limit="19.10"/>
                    <measurement group_id="O3" value="7.060" lower_limit="2.75" upper_limit="11.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.180" lower_limit="1.45" upper_limit="8.11"/>
                    <measurement group_id="O2" value="7.660" lower_limit="2.41" upper_limit="13.60"/>
                    <measurement group_id="O3" value="11.450" lower_limit="6.76" upper_limit="12.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Percent Fluctuation Over the Secondary Peak</title>
        <description>The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Percent Fluctuation Over the Secondary Peak</title>
          <description>The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>percentage of average concentration</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.945" lower_limit="57.64" upper_limit="252.39"/>
                    <measurement group_id="O2" value="127.274" lower_limit="47.14" upper_limit="183.19"/>
                    <measurement group_id="O3" value="141.300" lower_limit="73.92" upper_limit="210.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.055" lower_limit="34.50" upper_limit="191.68"/>
                    <measurement group_id="O2" value="104.207" lower_limit="58.02" upper_limit="139.50"/>
                    <measurement group_id="O3" value="101.956" lower_limit="79.06" upper_limit="147.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Swing Over the Secondary Peak</title>
        <description>The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Swing Over the Secondary Peak</title>
          <description>The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.&#xD;
Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.936" lower_limit="0.77" upper_limit="12.11"/>
                    <measurement group_id="O2" value="2.041" lower_limit="0.56" upper_limit="4.54"/>
                    <measurement group_id="O3" value="2.633" lower_limit="0.96" upper_limit="5.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.018" lower_limit="0.46" upper_limit="8.24"/>
                    <measurement group_id="O2" value="1.991" lower_limit="0.74" upper_limit="2.88"/>
                    <measurement group_id="O3" value="1.595" lower_limit="1.12" upper_limit="4.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>9-hydroxyrisperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak</title>
        <description>Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
        <time_frame>Day 2-29, Day 58-85</time_frame>
        <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>9-hydroxyrisperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak</title>
          <description>Results are reported across two timeframes:&#xD;
Secondary Peak, Injection 1 (Day 2 - Day 29)&#xD;
Secondary Peak, Injection 3 (Day 58 - Day 85)&#xD;
The PK sampling schedule was:&#xD;
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose&#xD;
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration</description>
          <population>The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Secondary Peak, Injection 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="216.000" lower_limit="24.00" upper_limit="504.00"/>
                    <measurement group_id="O2" value="168.000" lower_limit="24.00" upper_limit="579.02"/>
                    <measurement group_id="O3" value="216.000" lower_limit="24.00" upper_limit="574.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary Peak, Injection 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="228.000" lower_limit="24.00" upper_limit="408.00"/>
                    <measurement group_id="O2" value="264.000" lower_limit="24.00" upper_limit="336.00"/>
                    <measurement group_id="O3" value="216.000" lower_limit="168.00" upper_limit="552.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive and Negative Syndrome Scale (PANSS) Scores at Baseline and Days 28, 56, 84 and 106</title>
        <description>The switch from oral risperidone to RBP-7000 subcutaneous injections for efficacy markers used the PANSS scores. The PANSS assessment is a medical scale designed to measure symptom severity among patients with schizophrenia. Each item is rated on a scale of 1=absent to 7=extreme. PANSS consists of three components:&#xD;
The General Psychopathology Scale consists of 16 questions with a total range of 16 (no schizophrenia symptoms) to 112 (extreme schizophrenia symptoms).&#xD;
Both the Positive Scale and the Negative Scale consists of 7 questions with a total range of 7 (no schizophrenia symptoms) to 49 (extreme symptoms) on each scale.&#xD;
The PANSS range for assuring stability was a total PANSS General Psychopathology Scale score of 70 or less, with no score of 4 on any of the 7 questions in the Positive scale.</description>
        <time_frame>Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)</time_frame>
        <population>Safety</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive and Negative Syndrome Scale (PANSS) Scores at Baseline and Days 28, 56, 84 and 106</title>
          <description>The switch from oral risperidone to RBP-7000 subcutaneous injections for efficacy markers used the PANSS scores. The PANSS assessment is a medical scale designed to measure symptom severity among patients with schizophrenia. Each item is rated on a scale of 1=absent to 7=extreme. PANSS consists of three components:&#xD;
The General Psychopathology Scale consists of 16 questions with a total range of 16 (no schizophrenia symptoms) to 112 (extreme schizophrenia symptoms).&#xD;
Both the Positive Scale and the Negative Scale consists of 7 questions with a total range of 7 (no schizophrenia symptoms) to 49 (extreme symptoms) on each scale.&#xD;
The PANSS range for assuring stability was a total PANSS General Psychopathology Scale score of 70 or less, with no score of 4 on any of the 7 questions in the Positive scale.</description>
          <population>Safety</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: General Psychopathology Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0" lower_limit="21" upper_limit="34"/>
                    <measurement group_id="O2" value="24.0" lower_limit="21" upper_limit="32"/>
                    <measurement group_id="O3" value="27.0" lower_limit="22" upper_limit="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Positive Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" lower_limit="10" upper_limit="15"/>
                    <measurement group_id="O2" value="14.0" lower_limit="8" upper_limit="17"/>
                    <measurement group_id="O3" value="13.0" lower_limit="10" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Negative Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="11" upper_limit="24"/>
                    <measurement group_id="O2" value="18.0" lower_limit="9" upper_limit="23"/>
                    <measurement group_id="O3" value="18.0" lower_limit="13" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28: General Psychopathology Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0" lower_limit="19" upper_limit="33"/>
                    <measurement group_id="O2" value="26.0" lower_limit="20" upper_limit="46"/>
                    <measurement group_id="O3" value="27.0" lower_limit="22" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28: Positive Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" lower_limit="11" upper_limit="23"/>
                    <measurement group_id="O2" value="12.0" lower_limit="8" upper_limit="24"/>
                    <measurement group_id="O3" value="12.0" lower_limit="10" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28: Negative Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0" lower_limit="11" upper_limit="22"/>
                    <measurement group_id="O2" value="17.0" lower_limit="9" upper_limit="23"/>
                    <measurement group_id="O3" value="18.0" lower_limit="12" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56: General Psychopathology Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0" lower_limit="22" upper_limit="33"/>
                    <measurement group_id="O2" value="26.0" lower_limit="20" upper_limit="34"/>
                    <measurement group_id="O3" value="25.0" lower_limit="22" upper_limit="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56: Positive Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" lower_limit="9" upper_limit="22"/>
                    <measurement group_id="O2" value="13.0" lower_limit="9" upper_limit="21"/>
                    <measurement group_id="O3" value="11.5" lower_limit="10" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56: Negative Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.0" lower_limit="11" upper_limit="21"/>
                    <measurement group_id="O2" value="18.0" lower_limit="8" upper_limit="25"/>
                    <measurement group_id="O3" value="17.5" lower_limit="12" upper_limit="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84: General Psychopathology Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0" lower_limit="20" upper_limit="34"/>
                    <measurement group_id="O2" value="25.0" lower_limit="19" upper_limit="32"/>
                    <measurement group_id="O3" value="25.0" lower_limit="22" upper_limit="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84: Positive Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.5" lower_limit="9" upper_limit="19"/>
                    <measurement group_id="O2" value="12.5" lower_limit="8" upper_limit="18"/>
                    <measurement group_id="O3" value="12.5" lower_limit="10" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84: Negative Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.5" lower_limit="11" upper_limit="21"/>
                    <measurement group_id="O2" value="17.5" lower_limit="13" upper_limit="24"/>
                    <measurement group_id="O3" value="16.0" lower_limit="12" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 106: General Psychopathology Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.0" lower_limit="19" upper_limit="32"/>
                    <measurement group_id="O2" value="23.5" lower_limit="19" upper_limit="34"/>
                    <measurement group_id="O3" value="26.5" lower_limit="21" upper_limit="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 106: Positive Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" lower_limit="10" upper_limit="18"/>
                    <measurement group_id="O2" value="12.0" lower_limit="7" upper_limit="19"/>
                    <measurement group_id="O3" value="14.0" lower_limit="10" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 106: Negative Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" lower_limit="11" upper_limit="21"/>
                    <measurement group_id="O2" value="18.0" lower_limit="13" upper_limit="23"/>
                    <measurement group_id="O3" value="18.0" lower_limit="11" upper_limit="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Global Impression (CGI) Scores (Severity of Illness and Global Improvement) at Baseline and Days 28, 56, 84 and 106</title>
        <description>The switch from oral risperidone to RBP-7000 subcutaneous injections for efficacy markers used CGI scores. The CGI is used in the assessment of global illness severity and change in clinical condition over time in psychiatric patients.&#xD;
Severity of illness is measured on a 7-point scale with 1=normal, not at all ill and 7=among the most extremely ill patients.&#xD;
Global improvement is measured on a 7-point scale with 1=very much improved, 4=no change and 7=very much worse as compared to the severity of illness at baseline.</description>
        <time_frame>Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)</time_frame>
        <population>Safety</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression (CGI) Scores (Severity of Illness and Global Improvement) at Baseline and Days 28, 56, 84 and 106</title>
          <description>The switch from oral risperidone to RBP-7000 subcutaneous injections for efficacy markers used CGI scores. The CGI is used in the assessment of global illness severity and change in clinical condition over time in psychiatric patients.&#xD;
Severity of illness is measured on a 7-point scale with 1=normal, not at all ill and 7=among the most extremely ill patients.&#xD;
Global improvement is measured on a 7-point scale with 1=very much improved, 4=no change and 7=very much worse as compared to the severity of illness at baseline.</description>
          <population>Safety</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Severity of illness</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="3.00" upper_limit="3.00"/>
                    <measurement group_id="O2" value="3.0" lower_limit="3.00" upper_limit="3.00"/>
                    <measurement group_id="O3" value="3.0" lower_limit="3.00" upper_limit="3.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28: Severity of illness</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="3.00" upper_limit="3.00"/>
                    <measurement group_id="O2" value="3.0" lower_limit="3.00" upper_limit="4.00"/>
                    <measurement group_id="O3" value="3.0" lower_limit="3.00" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28: Global improvement</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="3.00" upper_limit="5.00"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.00" upper_limit="6.00"/>
                    <measurement group_id="O3" value="4.0" lower_limit="3.00" upper_limit="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56: Severity of illness</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="3.00" upper_limit="3.00"/>
                    <measurement group_id="O2" value="3.0" lower_limit="3.00" upper_limit="4.00"/>
                    <measurement group_id="O3" value="3.0" lower_limit="3.00" upper_limit="3.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56: Global improvement</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="4.00" upper_limit="5.00"/>
                    <measurement group_id="O2" value="4.0" lower_limit="4.00" upper_limit="5.00"/>
                    <measurement group_id="O3" value="4.0" lower_limit="4.00" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84: Severity of illness</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="3.00" upper_limit="3.00"/>
                    <measurement group_id="O2" value="3.0" lower_limit="3.00" upper_limit="3.00"/>
                    <measurement group_id="O3" value="3.0" lower_limit="3.00" upper_limit="3.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84: Global improvement</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="3.00" upper_limit="4.00"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.00" upper_limit="5.00"/>
                    <measurement group_id="O3" value="4.0" lower_limit="4.00" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 106: Severity of illness</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="3.00" upper_limit="3.00"/>
                    <measurement group_id="O2" value="3.0" lower_limit="3.00" upper_limit="3.00"/>
                    <measurement group_id="O3" value="3.0" lower_limit="3.00" upper_limit="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 106: Global improvement</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="2.00" upper_limit="4.00"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.00" upper_limit="5.00"/>
                    <measurement group_id="O3" value="4.0" lower_limit="3.00" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Assessment of the Abnormal Involuntary Movement Scale (AIMS) for Tardive Dyskinesia at Baseline and Days 28, 56, 84 and 106</title>
        <description>The switch from oral risperidone to RBP-7000 subcutaneous injections for safety markers used AIMS. The AIMS is a scale that aids in the early detection and ongoing monitoring of tardive dyskinesia, a movement disorder that can result from long-term treatment with antipsychotic medication. By assessing the participant's body movement in specific positions requiring rotation, a psychiatrist is able to determine whether abnormal facial or body movements exist.&#xD;
The total score is the sum of 7 questions assessing movement plus 3 questions representing global assessments on the overall level of involuntary movement severity, incapacitation due to involuntary movement, and patient's awareness of involuntary movement. Each of the 10 questions are scored on a 0 (none) - 4 (extremely severe) scale. Plus two dental status questions are scored on a 0 (no) - 1 (yes) scale. The total score is therefore a scale of 0 (normal) - 42 (advanced tardive dyskinesia).</description>
        <time_frame>Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)</time_frame>
        <population>Safety</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Global Assessment of the Abnormal Involuntary Movement Scale (AIMS) for Tardive Dyskinesia at Baseline and Days 28, 56, 84 and 106</title>
          <description>The switch from oral risperidone to RBP-7000 subcutaneous injections for safety markers used AIMS. The AIMS is a scale that aids in the early detection and ongoing monitoring of tardive dyskinesia, a movement disorder that can result from long-term treatment with antipsychotic medication. By assessing the participant's body movement in specific positions requiring rotation, a psychiatrist is able to determine whether abnormal facial or body movements exist.&#xD;
The total score is the sum of 7 questions assessing movement plus 3 questions representing global assessments on the overall level of involuntary movement severity, incapacitation due to involuntary movement, and patient's awareness of involuntary movement. Each of the 10 questions are scored on a 0 (none) - 4 (extremely severe) scale. Plus two dental status questions are scored on a 0 (no) - 1 (yes) scale. The total score is therefore a scale of 0 (normal) - 42 (advanced tardive dyskinesia).</description>
          <population>Safety</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0" upper_limit="12"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O3" value="1.0" lower_limit="0" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0" upper_limit="12"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O3" value="1.0" lower_limit="0" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0" upper_limit="12"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O3" value="1.0" lower_limit="0" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0" upper_limit="12"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O3" value="1.0" lower_limit="0" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 106</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0" upper_limit="12"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="5"/>
                    <measurement group_id="O3" value="0.5" lower_limit="0" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Simpson-Angus Scale (SAS) Score at Baseline and Days 28, 56, 84 and 106</title>
        <description>The switch from oral risperidone to RBP-7000 subcutaneous injections for safety markers used SAS. The SAS is a 10-item scale used to detect the presence of drug induced parkinsonism and extrapyramidal side effects, and evaluates symptom severity. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0 to 4 scale with 0=normal and 4=extreme description of the particular side effect. The total range is 0=no side effects observed to 40 = extreme of each of the 10 side effects.</description>
        <time_frame>Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)</time_frame>
        <population>Safety</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Simpson-Angus Scale (SAS) Score at Baseline and Days 28, 56, 84 and 106</title>
          <description>The switch from oral risperidone to RBP-7000 subcutaneous injections for safety markers used SAS. The SAS is a 10-item scale used to detect the presence of drug induced parkinsonism and extrapyramidal side effects, and evaluates symptom severity. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0 to 4 scale with 0=normal and 4=extreme description of the particular side effect. The total range is 0=no side effects observed to 40 = extreme of each of the 10 side effects.</description>
          <population>Safety</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 106</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Clinical Assessment of Akathisia Using the Barnes Akathisia Scale (BAS) at Baseline and Days 28, 56, 84 and 106</title>
        <description>The BAS is a scale that detects the presence and severity of any drug induced akathisia. The scale measures objective and subjective effects such as restlessness and awareness of restlessness, respectively. Participants are observed while seated, then while standing and engaged in neutral conversation. Symptoms observed during additional situations, such as participant behavior on the ward, may also be rated. Subjective phenomena should be elicited through direct questioning of the participant. The global clinical assessment is reported on a scale of 0 to 5, where 0 = absent and 5 = severe akathisia.</description>
        <time_frame>Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)</time_frame>
        <population>Safety</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Global Clinical Assessment of Akathisia Using the Barnes Akathisia Scale (BAS) at Baseline and Days 28, 56, 84 and 106</title>
          <description>The BAS is a scale that detects the presence and severity of any drug induced akathisia. The scale measures objective and subjective effects such as restlessness and awareness of restlessness, respectively. Participants are observed while seated, then while standing and engaged in neutral conversation. Symptoms observed during additional situations, such as participant behavior on the ward, may also be rated. Subjective phenomena should be elicited through direct questioning of the participant. The global clinical assessment is reported on a scale of 0 to 5, where 0 = absent and 5 = severe akathisia.</description>
          <population>Safety</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 106</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants With Suicidal Ideation or Behavior as Identified Using the Columbia-Suicide Severity Rating Scale (C-SSRS) Score at Baseline and Days 28, 56, 84 and 106</title>
        <description>The C-SSRS is a scale developed by the National Institute of Mental Health trial group as a counterpart to the FDA's categorization of suicidal events. It was developed by a careful review and consequent categorization of thoughts and behavior that were statistically identified as significantly related to suicidal behavior. The scale captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors throughout lifetime at screening, baseline, and for the time interval since last administration for repeat administrations during a study.&#xD;
This outcome reports the number of participants with suicidal ideation or behavior.</description>
        <time_frame>Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)</time_frame>
        <population>Safety</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, RBP-7000 60 mg</title>
            <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2, RBP-7000 90 mg</title>
            <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3, RBP-7000 120 mg</title>
            <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Suicidal Ideation or Behavior as Identified Using the Columbia-Suicide Severity Rating Scale (C-SSRS) Score at Baseline and Days 28, 56, 84 and 106</title>
          <description>The C-SSRS is a scale developed by the National Institute of Mental Health trial group as a counterpart to the FDA's categorization of suicidal events. It was developed by a careful review and consequent categorization of thoughts and behavior that were statistically identified as significantly related to suicidal behavior. The scale captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors throughout lifetime at screening, baseline, and for the time interval since last administration for repeat administrations during a study.&#xD;
This outcome reports the number of participants with suicidal ideation or behavior.</description>
          <population>Safety</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="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Suicidal ideation or behavior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28: Suicidal ideation or behavior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56: Suicidal ideation or behavior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84: Suicidal ideation or behavior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 106: Suicidal ideation or behavior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 1 to Day 106</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1, RBP-7000 60 mg</title>
          <description>Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2, RBP-7000 90 mg</title>
          <description>Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.</description>
        </group>
        <group group_id="E3">
          <title>Cohort 3, RBP-7000 120 mg</title>
          <description>Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (15.0)</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="11" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Otorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Influenza-like illness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Extrapyramidal disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Drooling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Akathisia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pyuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Sexual dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dermititis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </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/NCT01677377
org study id: RB-US-09-0009
nct id: NCT01677377
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Evaluate the safety and tolerability of multiple subcutaneous injections of various dosages
      of risperidone with clinically stable schizophrenia
This will be an open-label, Phase 2A, multiple ascending dose study in 1 to 3 sites, designed
      to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple
      subcutaneous injections of 60mg, 90mg, and 120mg doses of risperidone in the RBP-7000
      formulation, in subjects with clinically-stable schizophrenia who are on a once daily stable
      dose of 2mg, 3mg, or 4mg of oral risperidone.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Summary of Participants With Treatment-Emergent Adverse Events (TEAE)
time frame: Day 1 to Day 106
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: Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)
time frame: Day 1-2, Day 57-58
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
AUC0-24 calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak
time frame: Day 1-2, Day 57-58
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
Cmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak
time frame: Day 1-2, Day 57-58
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
Tmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)
time frame: Day 1-28, Day 57-84
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
AUCtau calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile
time frame: Day 1-28, Day 57-84
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile
time frame: Day 1-28, Day 57-84
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile
time frame: Day 1-28, Day 57-84
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Percent Fluctuation Over the PK Profile
time frame: Day 1-28, Day 57-84
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Swing Over the PK Profile
time frame: Day 1-28, Day 57-84
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile
time frame: Day 1-28, Day 57-84
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))
time frame: Day 1-28, Day 57-84
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))
time frame: Day 1-28, Day 57-84
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)
time frame: Day 2-29, Day 58-85
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 at time of study drug administration.
measure: Total Risperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)
time frame: Day 2-29, Day 58-85
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)
time frame: Day 2-29, Day 58-85
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak
time frame: Day 2-29, Day 58-85
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Percent Fluctuation Over the Secondary Peak
time frame: Day 2-29, Day 58-85
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Swing Over the Secondary Peak
time frame: Day 2-29, Day 58-85
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Total Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak
time frame: Day 2-29, Day 58-85
description: Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)
time frame: Day 1-2, Day 57-58
description: AUC0-24 calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak
time frame: Day 1-2, Day 57-58
description: Cmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak
time frame: Day 1-2, Day 57-58
description: Tmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)
time frame: Day 1-28, Day 57-84
description: AUCtau calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile
time frame: Day 1-28, Day 57-84
description: The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile
time frame: Day 1-28, Day 57-84
description: Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile
time frame: Day 1-28, Day 57-84
description: Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Percent Fluctuation Over the PK Profile
time frame: Day 1-28, Day 57-84
description: The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Swing Over the PK Profile
time frame: Day 1-28, Day 57-84
description: The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile
time frame: Day 1-28, Day 57-84
description: Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))
time frame: Day 1-28, Day 57-84
description: Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))
time frame: Day 1-28, Day 57-84
description: Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)
time frame: Day 2-29, Day 58-85
description: Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)
time frame: Day 2-29, Day 58-85
description: The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)
time frame: Day 2-29, Day 58-85
description: Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak
time frame: Day 2-29, Day 58-85
description: Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Percent Fluctuation Over the Secondary Peak
time frame: Day 2-29, Day 58-85
description: The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Swing Over the Secondary Peak
time frame: Day 2-29, Day 58-85
description: The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak
time frame: Day 2-29, Day 58-85
description: Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)
time frame: Day 1-2, Day 57-58
description: AUC0-24 calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak
time frame: Day 1-2, Day 57-58
description: Cmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak
time frame: Day 1-2, Day 57-58
description: Tmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)
time frame: Day 1-28, Day 57-84
description: AUCtau calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile
time frame: Day 1-28, Day 57-84
description: The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile
time frame: Day 1-28, Day 57-84
description: Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile
time frame: Day 1-28, Day 57-84
description: Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Percent Fluctuation Over the PK Profile
time frame: Day 1-28, Day 57-84
description: The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Swing Over the PK Profile
time frame: Day 1-28, Day 57-84
description: The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile
time frame: Day 1-28, Day 57-84
description: Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))
time frame: Day 1-28, Day 57-84
description: Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))
time frame: Day 1-28, Day 57-84
description: Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)
time frame: Day 2-29, Day 58-85
description: Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)
time frame: Day 2-29, Day 58-85
description: The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)
time frame: Day 2-29, Day 58-85
description: Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak
time frame: Day 2-29, Day 58-85
description: Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Percent Fluctuation Over the Secondary Peak
time frame: Day 2-29, Day 58-85
description: The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Swing Over the Secondary Peak
time frame: Day 2-29, Day 58-85
description: The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: 9-hydroxyrisperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak
time frame: Day 2-29, Day 58-85
description: Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
measure: Positive and Negative Syndrome Scale (PANSS) Scores at Baseline and Days 28, 56, 84 and 106
time frame: Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
description: The switch from oral risperidone to RBP-7000 subcutaneous injections for efficacy markers used the PANSS scores. The PANSS assessment is a medical scale designed to measure symptom severity among patients with schizophrenia. Each item is rated on a scale of 1=absent to 7=extreme. PANSS consists of three components:
The General Psychopathology Scale consists of 16 questions with a total range of 16 (no schizophrenia symptoms) to 112 (extreme schizophrenia symptoms).
Both the Positive Scale and the Negative Scale consists of 7 questions with a total range of 7 (no schizophrenia symptoms) to 49 (extreme symptoms) on each scale.
The PANSS range for assuring stability was a total PANSS General Psychopathology Scale score of 70 or less, with no score of 4 on any of the 7 questions in the Positive scale.
measure: Clinical Global Impression (CGI) Scores (Severity of Illness and Global Improvement) at Baseline and Days 28, 56, 84 and 106
time frame: Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
description: The switch from oral risperidone to RBP-7000 subcutaneous injections for efficacy markers used CGI scores. The CGI is used in the assessment of global illness severity and change in clinical condition over time in psychiatric patients.
Severity of illness is measured on a 7-point scale with 1=normal, not at all ill and 7=among the most extremely ill patients.
Global improvement is measured on a 7-point scale with 1=very much improved, 4=no change and 7=very much worse as compared to the severity of illness at baseline.
measure: Global Assessment of the Abnormal Involuntary Movement Scale (AIMS) for Tardive Dyskinesia at Baseline and Days 28, 56, 84 and 106
time frame: Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
description: The switch from oral risperidone to RBP-7000 subcutaneous injections for safety markers used AIMS. The AIMS is a scale that aids in the early detection and ongoing monitoring of tardive dyskinesia, a movement disorder that can result from long-term treatment with antipsychotic medication. By assessing the participant's body movement in specific positions requiring rotation, a psychiatrist is able to determine whether abnormal facial or body movements exist.
The total score is the sum of 7 questions assessing movement plus 3 questions representing global assessments on the overall level of involuntary movement severity, incapacitation due to involuntary movement, and patient's awareness of involuntary movement. Each of the 10 questions are scored on a 0 (none) - 4 (extremely severe) scale. Plus two dental status questions are scored on a 0 (no) - 1 (yes) scale. The total score is therefore a scale of 0 (normal) - 42 (advanced tardive dyskinesia).
measure: Total Simpson-Angus Scale (SAS) Score at Baseline and Days 28, 56, 84 and 106
time frame: Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
description: The switch from oral risperidone to RBP-7000 subcutaneous injections for safety markers used SAS. The SAS is a 10-item scale used to detect the presence of drug induced parkinsonism and extrapyramidal side effects, and evaluates symptom severity. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0 to 4 scale with 0=normal and 4=extreme description of the particular side effect. The total range is 0=no side effects observed to 40 = extreme of each of the 10 side effects.
measure: Global Clinical Assessment of Akathisia Using the Barnes Akathisia Scale (BAS) at Baseline and Days 28, 56, 84 and 106
time frame: Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
description: The BAS is a scale that detects the presence and severity of any drug induced akathisia. The scale measures objective and subjective effects such as restlessness and awareness of restlessness, respectively. Participants are observed while seated, then while standing and engaged in neutral conversation. Symptoms observed during additional situations, such as participant behavior on the ward, may also be rated. Subjective phenomena should be elicited through direct questioning of the participant. The global clinical assessment is reported on a scale of 0 to 5, where 0 = absent and 5 = severe akathisia.
measure: Participants With Suicidal Ideation or Behavior as Identified Using the Columbia-Suicide Severity Rating Scale (C-SSRS) Score at Baseline and Days 28, 56, 84 and 106
time frame: Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
description: The C-SSRS is a scale developed by the National Institute of Mental Health trial group as a counterpart to the FDA's categorization of suicidal events. It was developed by a careful review and consequent categorization of thoughts and behavior that were statistically identified as significantly related to suicidal behavior. The scale captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors throughout lifetime at screening, baseline, and for the time interval since last administration for repeat administrations during a study.
This outcome reports the number of participants with suicidal ideation or behavior.
arm group label: Cohort 1, RBP-7000 60 mg
arm group type: Experimental
description: Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
arm group label: Cohort 2, RBP-7000 90 mg
arm group type: Experimental
description: Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
arm group label: Cohort 3, RBP-7000 120 mg
arm group type: Experimental
description: Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
intervention type: Drug
intervention name: Risperidone
description: Oral risperidone was supplied as 2, 3, or 4 mg tablets in blister packs or bottles and taken daily only during the oral dosing periods of the study, days -14 through -8 (if applicable), days -7 through -1, and days 85 through 87.
arm group label: Cohort 1, RBP-7000 60 mg
arm group label: Cohort 2, RBP-7000 90 mg
arm group label: Cohort 3, RBP-7000 120 mg
other name: Risperdal
intervention type: Drug
intervention name: RBP-7000
description: RBP-7000 60 mg, 90 mg, and 120 mg were a mixture of the ATRIGEL® Delivery System and 60 mg, 90 mg, or 120 mg risperidone, respectively. Treatment was delivered as subcutaneous injections on study days 1, 29 and 57.
arm group label: Cohort 1, RBP-7000 60 mg
arm group label: Cohort 2, RBP-7000 90 mg
arm group label: Cohort 3, RBP-7000 120 mg
other name: risperidone in Atrigel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Philippa Whitelaw, Sr. Dir of Proj Deliver
role: Study Director
affiliation: Pharmaceutical Research Associates
last name: Ashley Huston, PMP
role: Study Director
affiliation: Pharmaceutical Research Associates
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Risperidone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 