<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/NCT01678924</url>
  </required_header>
  <id_info>
    <org_study_id>214868-007</org_study_id>
    <secondary_id>2012-002240-24</secondary_id>
    <nct_id>NCT01678924</nct_id>
  </id_info>
  <brief_title>A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia&#xD;
      (PHN).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Average Pain Intensity Score - Cohort 1</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. Patients used the 11-point Likert scale, with anchors at 0 = &quot;no pain&quot; and 10 = &quot;pain as bad as you can imagine&quot; Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Average Pain Intensity Score - Cohort 2</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. patients used the 11-point Likert scale, with anchors at 0 = &quot;no pain&quot; and 10 = &quot;pain as bad as you can imagine&quot; Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1</measure>
    <time_frame>Baseline to Week 1</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3</measure>
    <time_frame>Baseline to Week 3</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease), and in 10% increments, up to 100% improvement, in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5</measure>
    <time_frame>Baseline to Week 5</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6</measure>
    <time_frame>Baseline to Week 6</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7</measure>
    <time_frame>Baseline to Week 7</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9</measure>
    <time_frame>Baseline to Week 9</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10</measure>
    <time_frame>Baseline to Week 10</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11</measure>
    <time_frame>Baseline to Week 11</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1</measure>
    <time_frame>Baseline to Week 1</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3</measure>
    <time_frame>Baseline to Week 3</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5</measure>
    <time_frame>Baseline to Week 5</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6</measure>
    <time_frame>Baseline to Week 6</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7</measure>
    <time_frame>Baseline to Week 7</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9</measure>
    <time_frame>Baseline to Week 9</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10</measure>
    <time_frame>Baseline to Week 10</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11</measure>
    <time_frame>Baseline to Week 11</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient and that the patient was asked to circle their MASP on with a black marker. Areas of pain were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Area of Allodynia - Cohort 1 - Week 2</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Area of Allodynia - Cohort 1 - Week 4</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Area of Allodynia - Cohort 1 - Week 8</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Area of Allodynia - Cohort 1 - Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Area of Allodynia - Cohort 2 - Week 2</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Area of Allodynia - Cohort 2 - Week 4</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Area of Allodynia - Cohort 2 - Week 8</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Area of Allodynia - Cohort 2 - Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Neuralgia, Postherpetic</condition>
  <arm_group>
    <arm_group_label>AGN-214868 Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AGN-214868 Dose 1 given as injections into the area of pain on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-214868 Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AGN-214868 Dose 2 given as injections into the area of pain on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-214868 Placebo (Vehicle)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-214868 Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AGN-214868 Dose 3 given as injections into the area of pain on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-214868</intervention_name>
    <description>AGN-214868 given as injections into the area of pain on Day 1.</description>
    <arm_group_label>AGN-214868 Dose 1</arm_group_label>
    <arm_group_label>AGN-214868 Dose 2</arm_group_label>
    <arm_group_label>AGN-214868 Dose 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-214868 Placebo (Vehicle)</intervention_name>
    <description>AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.</description>
    <arm_group_label>AGN-214868 Placebo (Vehicle)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postherpetic neuralgia with pain present for at least 9 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active herpes zoster skin rash&#xD;
&#xD;
          -  Anticipated treatment for postherpetic neuralgia during the first 3 months of the&#xD;
             study, including oral and topical medications, acupuncture, spinal cord stimulation,&#xD;
             transcutaneous nerve stimulation (TNS), or trigger point injection&#xD;
&#xD;
          -  Anticipated treatment with pain medication for the treatment of postherpetic neuralgia&#xD;
             during the first 3 months of the study&#xD;
&#xD;
          -  Use of capsaicin treatment for postherpetic neuralgia within 6 months, or anticipated&#xD;
             use during the first 3 months of the study&#xD;
&#xD;
          -  Use of botulinum toxin of any serotype for any reason within 6 months, or anticipated&#xD;
             use during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Agave Clinical Research, LLC</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Territory Neurology &amp; Research Institute</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuro-Pain Medical Center</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loma Linda University</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern California Research Corp</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurological Research Institute</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alpine Clinical Research Center</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Mile High Research Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Clinical Research</name>
      <address>
        <city>Edgewater</city>
        <state>Florida</state>
        <zip>32132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug Studies America</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Injury Care Research, LLC</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Pain Center</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beacon Clinical Research</name>
      <address>
        <city>Brockton</city>
        <state>Massachusetts</state>
        <zip>02301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Springfield Neurology Associates, LLC</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Head Pain and Neurology Institute</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quest Research Institute</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Pharmaceutical Research</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinvest Headache Care Center</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albuquerque Neuroscience, Inc.</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical Research Network, LLC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Island Neurological Associates, P.C.</name>
      <address>
        <city>Plainview</city>
        <state>New York</state>
        <zip>11803-4491</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plains Medical Clinic</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>COR Clinical Research, LLC</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny Pain Management</name>
      <address>
        <city>Altoona</city>
        <state>Pennsylvania</state>
        <zip>16602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Medical Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of South Carolina, LLC</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PharmaCorp Clinical Trials, Inc</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29412</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of Charleston</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Studies</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Neuroscience Center of Washington</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SMZ-Ost Donauspital</name>
      <address>
        <city>Vienna</city>
        <zip>A-1220</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH Wien</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilhelminenspital der Stadt Wien</name>
      <address>
        <city>Wien</city>
        <zip>1160</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pro scientia med im MARE Klinikum</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24119</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berlin Research Centre</name>
      <address>
        <city>Berlin</city>
        <zip>12627</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regionales Schmerzzentrum DGS</name>
      <address>
        <city>Bielefeld</city>
        <zip>33602</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bochum Research Centre</name>
      <address>
        <city>Bochum</city>
        <zip>44787</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Das Schmerzzentrum Celle</name>
      <address>
        <city>Celle</city>
        <zip>29221</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ambulant study centre</name>
      <address>
        <city>Cologne</city>
        <zip>50935</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiter des Universitats Schmerz Centrums (USC)</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuro-Consil GmbH</name>
      <address>
        <city>Düsseldorf</city>
        <zip>D-40212</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frankfurt Research Centre</name>
      <address>
        <city>Frankfurt</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schmerz und Palliativzentrum Fulda</name>
      <address>
        <city>Fulda</city>
        <zip>36039</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schmerz und Palliativ- Zentrum Goeppingen</name>
      <address>
        <city>Goeppingen</city>
        <zip>73033</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Hanau GmbH</name>
      <address>
        <city>Hanau</city>
        <zip>63450</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologische Praxis Heidenheim</name>
      <address>
        <city>Heidenheim</city>
        <zip>89518</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facharzt fur Neurologie</name>
      <address>
        <city>Hoppegarten</city>
        <zip>15366</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schmerzklinik Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medamed GmbH</name>
      <address>
        <city>Leipzig</city>
        <zip>04109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leipzig Research Centre</name>
      <address>
        <city>Leipzig</city>
        <zip>D-04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magdeburg Research Centre</name>
      <address>
        <city>Magdeburg</city>
        <zip>39104</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regionales Schmerz- und Palliativ Zentrum DGS Mainz</name>
      <address>
        <city>Mainz</city>
        <zip>55116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schmerztherapiezentrum Villingen-Schwenningen</name>
      <address>
        <city>Villingen-Schwenningen</city>
        <zip>D-78052</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poznański Ośrodek Medyczny NOVAMED</name>
      <address>
        <city>Poznan</city>
        <state>Poznañ</state>
        <zip>60-773</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medica Pro Familia Sp. Z.o.o SKA</name>
      <address>
        <city>Gdynia</city>
        <zip>81338</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medica Pro Familia Sp. Z.o.o SKA</name>
      <address>
        <city>Katowice</city>
        <zip>40-954</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malopolskie Centrum Medyczne S.C.</name>
      <address>
        <city>Krakow</city>
        <zip>30-510</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specjalistyczny Gabinet Neurologiczny</name>
      <address>
        <city>Krakow</city>
        <zip>30-539</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nzoz Neuromed</name>
      <address>
        <city>Lublin</city>
        <zip>20-064</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Neuro-Kard</name>
      <address>
        <city>Poznan</city>
        <zip>61-853</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niepubliczny Zaklad Opieki Zdrowotnej</name>
      <address>
        <city>Swidnik</city>
        <zip>21-040</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osrodek Badan Klinicznych Euromedis Sp. z o.o.</name>
      <address>
        <city>Szczecin</city>
        <zip>70-111</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Przychodnia Specjalistyczna PROSEN</name>
      <address>
        <city>Warszawa</city>
        <zip>01-231</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medica Pro Familia Warszawa</name>
      <address>
        <city>Warszawa</city>
        <zip>01-868</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus SCM sp. z o.o.</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-088</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Poland</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Australia</country>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <results_first_submitted>August 2, 2016</results_first_submitted>
  <results_first_submitted_qc>December 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 7, 2020</results_first_posted>
  <last_update_submitted>December 19, 2019</last_update_submitted>
  <last_update_submitted_qc>December 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Neuralgia, Postherpetic</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AGN 214868 130µg</title>
          <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
        </group>
        <group group_id="P2">
          <title>AGN 214868 65µg</title>
          <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
        </group>
        <group group_id="P3">
          <title>AGN 214868 32.5µg</title>
          <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="63"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="123"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="51"/>
                <participants group_id="P3" count="28"/>
                <participants group_id="P4" count="105"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="5"/>
              </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="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Personal Reasons</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="7"/>
              </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="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to attend scheduled visits</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety population, consisting of patients who received 1 dose of study drug in the study, included 280 patients</population>
      <group_list>
        <group group_id="B1">
          <title>AGN 214868 130µg</title>
          <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
        </group>
        <group group_id="B2">
          <title>AGN 214868 65µg</title>
          <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
        </group>
        <group group_id="B3">
          <title>AGN 214868 32.5µg</title>
          <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="64"/>
            <count group_id="B2" value="63"/>
            <count group_id="B3" value="30"/>
            <count group_id="B4" value="123"/>
            <count group_id="B5" value="280"/>
          </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="66.6" spread="10.47"/>
                    <measurement group_id="B2" value="65.3" spread="12.82"/>
                    <measurement group_id="B3" value="65.0" spread="11.99"/>
                    <measurement group_id="B4" value="67.0" spread="8.13"/>
                    <measurement group_id="B5" value="66.3" spread="10.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>18 years to less than 40 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 years to less than 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="46"/>
                    <measurement group_id="B5" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>65 years and over</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="77"/>
                    <measurement group_id="B5" value="178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="50"/>
                    <measurement group_id="B5" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="73"/>
                    <measurement group_id="B5" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="112"/>
                    <measurement group_id="B5" value="246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" 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="84.9" spread="19.15"/>
                    <measurement group_id="B2" value="82.3" spread="17.67"/>
                    <measurement group_id="B3" value="80.0" spread="14.48"/>
                    <measurement group_id="B4" value="78.8" spread="17.83"/>
                    <measurement group_id="B5" value="81.1" spread="17.86"/>
                  </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="169.8" spread="10.22"/>
                    <measurement group_id="B2" value="167.7" spread="10.98"/>
                    <measurement group_id="B3" value="169.1" spread="8.91"/>
                    <measurement group_id="B4" value="166.4" spread="9.07"/>
                    <measurement group_id="B5" value="167.7" spread="9.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Average Pain Intensity Score - Cohort 1</title>
        <description>The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. Patients used the 11-point Likert scale, with anchors at 0 = &quot;no pain&quot; and 10 = &quot;pain as bad as you can imagine&quot; Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>Two cohorts of patients with postherpetic neuralgia (PHN) were randomized to receive 1 treatment of either AGN-214868 (cohort 1: 32.5 or 65 μg; cohort 2: 130 μg) or placebo. Cohort 1 includes 154 patients from the modified intent to treat (mITT) population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Average Pain Intensity Score - Cohort 1</title>
          <description>The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. Patients used the 11-point Likert scale, with anchors at 0 = &quot;no pain&quot; and 10 = &quot;pain as bad as you can imagine&quot; Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.</description>
          <population>Two cohorts of patients with postherpetic neuralgia (PHN) were randomized to receive 1 treatment of either AGN-214868 (cohort 1: 32.5 or 65 μg; cohort 2: 130 μg) or placebo. Cohort 1 includes 154 patients from the modified intent to treat (mITT) population</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.88" lower_limit="-1.249" upper_limit="-0.538"/>
                    <measurement group_id="O2" value="-1.02" lower_limit="-1.380" upper_limit="-0.587"/>
                    <measurement group_id="O3" value="-1.11" lower_limit="-1.425" upper_limit="-0.808"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.33" lower_limit="-1.746" upper_limit="-0.968"/>
                    <measurement group_id="O2" value="-1.56" lower_limit="-1.963" upper_limit="-1.017"/>
                    <measurement group_id="O3" value="-1.57" lower_limit="-1.970" upper_limit="-1.174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.66" lower_limit="-2.143" upper_limit="-1.203"/>
                    <measurement group_id="O2" value="-1.93" lower_limit="-2.426" upper_limit="-1.227"/>
                    <measurement group_id="O3" value="-1.84" lower_limit="-2.248" upper_limit="-1.388"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.78" lower_limit="-2.277" upper_limit="-1.310"/>
                    <measurement group_id="O2" value="-2.20" lower_limit="-2.721" upper_limit="-1.432"/>
                    <measurement group_id="O3" value="-1.98" lower_limit="-2.423" upper_limit="-1.482"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.83" lower_limit="-2.321" upper_limit="-1.384"/>
                    <measurement group_id="O2" value="-2.19" lower_limit="-2.675" upper_limit="-1.379"/>
                    <measurement group_id="O3" value="-2.10" lower_limit="-2.557" upper_limit="-1.554"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.97" lower_limit="-2.442" upper_limit="-1.495"/>
                    <measurement group_id="O2" value="-2.07" lower_limit="-2.597" upper_limit="-1.297"/>
                    <measurement group_id="O3" value="-2.34" lower_limit="-2.755" upper_limit="-1.697"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.00" lower_limit="-2.481" upper_limit="-1.506"/>
                    <measurement group_id="O2" value="-2.08" lower_limit="-2.572" upper_limit="-1.328"/>
                    <measurement group_id="O3" value="-2.32" lower_limit="-2.746" upper_limit="-1.673"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.11" lower_limit="-2.591" upper_limit="-1.618"/>
                    <measurement group_id="O2" value="-2.02" lower_limit="-2.530" upper_limit="-1.263"/>
                    <measurement group_id="O3" value="-2.40" lower_limit="-2.825" upper_limit="-1.745"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.21" lower_limit="-2.66" upper_limit="-1.701"/>
                    <measurement group_id="O2" value="-2.15" lower_limit="-2.682" upper_limit="-1.352"/>
                    <measurement group_id="O3" value="-2.52" lower_limit="-2.805" upper_limit="-1.733"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.28" lower_limit="-2.679" upper_limit="-1.674"/>
                    <measurement group_id="O2" value="-2.29" lower_limit="-2.812" upper_limit="-1.481"/>
                    <measurement group_id="O3" value="-2.48" lower_limit="-2.743" upper_limit="-1.634"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.27" lower_limit="-2.684" upper_limit="-1.672"/>
                    <measurement group_id="O2" value="-2.46" lower_limit="-2.996" upper_limit="-1.570"/>
                    <measurement group_id="O3" value="-2.56" lower_limit="-2.807" upper_limit="-1.724"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.20" lower_limit="-2.626" upper_limit="-1.600"/>
                    <measurement group_id="O2" value="-2.53" lower_limit="-3.061" upper_limit="-1.605"/>
                    <measurement group_id="O3" value="-2.65" lower_limit="-2.886" upper_limit="-1.783"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Average Pain Intensity Score - Cohort 2</title>
        <description>The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. patients used the 11-point Likert scale, with anchors at 0 = &quot;no pain&quot; and 10 = &quot;pain as bad as you can imagine&quot; Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>Two cohorts of patients with postherpetic neuralgia (PHN) were randomized to receive 1 treatment of either AGN-214868 (cohort 1: 32.5 or 65 μg; cohort 2: 130 μg) or placebo. Cohort 2 includes 125 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Average Pain Intensity Score - Cohort 2</title>
          <description>The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. patients used the 11-point Likert scale, with anchors at 0 = &quot;no pain&quot; and 10 = &quot;pain as bad as you can imagine&quot; Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.</description>
          <population>Two cohorts of patients with postherpetic neuralgia (PHN) were randomized to receive 1 treatment of either AGN-214868 (cohort 1: 32.5 or 65 μg; cohort 2: 130 μg) or placebo. Cohort 2 includes 125 patients from the mITT population</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.78" lower_limit="-1.093" upper_limit="-0.451"/>
                    <measurement group_id="O2" value="-0.88" lower_limit="-1.190" upper_limit="-0.492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.12" lower_limit="-1.508" upper_limit="-0.701"/>
                    <measurement group_id="O2" value="-1.37" lower_limit="-1.791" upper_limit="-0.799"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.45" lower_limit="-1.788" upper_limit="-0.952"/>
                    <measurement group_id="O2" value="-1.65" lower_limit="-2.064" upper_limit="-1.057"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.62" lower_limit="-1.934" upper_limit="-1.072"/>
                    <measurement group_id="O2" value="-1.90" lower_limit="-2.344" upper_limit="-1.269"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.88" lower_limit="-2.202" upper_limit="-1.301"/>
                    <measurement group_id="O2" value="-1.88" lower_limit="-2.366" upper_limit="-1.257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.04" lower_limit="-2.226" upper_limit="-1.305"/>
                    <measurement group_id="O2" value="-1.90" lower_limit="-2.339" upper_limit="-1.235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.14" lower_limit="-2.345" upper_limit="-1.352"/>
                    <measurement group_id="O2" value="-1.90" lower_limit="-2.352" upper_limit="-1.225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.29" lower_limit="-2.405" upper_limit="-1.404"/>
                    <measurement group_id="O2" value="-1.96" lower_limit="-2.412" upper_limit="-1.270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.35" lower_limit="-2.493" upper_limit="-1.497"/>
                    <measurement group_id="O2" value="-2.00" lower_limit="-2.457" upper_limit="-1.293"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.44" lower_limit="-2.584" upper_limit="-1.557"/>
                    <measurement group_id="O2" value="-2.04" lower_limit="-2.515" upper_limit="-1.311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.49" lower_limit="-2.647" upper_limit="-1.581"/>
                    <measurement group_id="O2" value="-2.03" lower_limit="-2.489" upper_limit="-1.314"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.49" lower_limit="-2.659" upper_limit="-1.632"/>
                    <measurement group_id="O2" value="-2.03" lower_limit="-2.538" upper_limit="-1.354"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 1</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.0"/>
                    <measurement group_id="O2" value="33.3"/>
                    <measurement group_id="O3" value="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0"/>
                    <measurement group_id="O2" value="40.0"/>
                    <measurement group_id="O3" value="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 3</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.0"/>
                    <measurement group_id="O2" value="50.0"/>
                    <measurement group_id="O3" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease), and in 10% increments, up to 100% improvement, in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease), and in 10% increments, up to 100% improvement, in average pain intensity score at each week compared with baseline</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.7"/>
                    <measurement group_id="O2" value="53.3"/>
                    <measurement group_id="O3" value="50.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 5</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.7"/>
                    <measurement group_id="O2" value="53.3"/>
                    <measurement group_id="O3" value="52.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 6</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.4"/>
                    <measurement group_id="O2" value="50.0"/>
                    <measurement group_id="O3" value="54.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 7</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.3"/>
                    <measurement group_id="O2" value="56.7"/>
                    <measurement group_id="O3" value="50.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.1"/>
                    <measurement group_id="O2" value="50.0"/>
                    <measurement group_id="O3" value="55.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 9</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.6"/>
                    <measurement group_id="O2" value="51.9"/>
                    <measurement group_id="O3" value="51.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 10</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.4"/>
                    <measurement group_id="O2" value="53.6"/>
                    <measurement group_id="O3" value="55.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 11</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.2"/>
                    <measurement group_id="O2" value="53.6"/>
                    <measurement group_id="O3" value="59.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.0"/>
                    <measurement group_id="O2" value="63.0"/>
                    <measurement group_id="O3" value="63.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 1</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3"/>
                    <measurement group_id="O2" value="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.8"/>
                    <measurement group_id="O2" value="27.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 3</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.5"/>
                    <measurement group_id="O2" value="39.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.0"/>
                    <measurement group_id="O2" value="43.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 5</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.1"/>
                    <measurement group_id="O2" value="45.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 6</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.3"/>
                    <measurement group_id="O2" value="45.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 7</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="48.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.9"/>
                    <measurement group_id="O2" value="49.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 9</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.8"/>
                    <measurement group_id="O2" value="45.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 10</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.7"/>
                    <measurement group_id="O2" value="47.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 11</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.0"/>
                    <measurement group_id="O2" value="42.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12</title>
        <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12</title>
          <description>Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.4"/>
                    <measurement group_id="O2" value="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2</title>
        <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient and that the patient was asked to circle their MASP on with a black marker. Areas of pain were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2</title>
          <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient and that the patient was asked to circle their MASP on with a black marker. Areas of pain were quantified at a central reading center.</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.07" lower_limit="-37.544" upper_limit="-13.564"/>
                    <measurement group_id="O2" value="-34.07" lower_limit="-60.871" upper_limit="-4.114"/>
                    <measurement group_id="O3" value="-26.10" lower_limit="-38.580" upper_limit="-14.053"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4</title>
        <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4</title>
          <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.65" lower_limit="-40.978" upper_limit="-15.412"/>
                    <measurement group_id="O2" value="-25.96" lower_limit="-49.316" upper_limit="0.309"/>
                    <measurement group_id="O3" value="-32.23" lower_limit="-48.543" upper_limit="-16.214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8</title>
        <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8</title>
          <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.86" lower_limit="-45.876" upper_limit="-15.566"/>
                    <measurement group_id="O2" value="-37.18" lower_limit="-64.825" upper_limit="-1.989"/>
                    <measurement group_id="O3" value="-34.04" lower_limit="-48.026" upper_limit="-22.134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12</title>
        <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12</title>
          <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.99" lower_limit="-46.118" upper_limit="-17.138"/>
                    <measurement group_id="O2" value="-31.40" lower_limit="-61.185" upper_limit="3.853"/>
                    <measurement group_id="O3" value="-35.03" lower_limit="-53.242" upper_limit="-18.425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2</title>
        <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2</title>
          <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.86" lower_limit="-38.087" upper_limit="18.020"/>
                    <measurement group_id="O2" value="-27.52" lower_limit="-43.841" upper_limit="-10.854"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4</title>
        <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4</title>
          <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.23" lower_limit="-48.893" upper_limit="3.903"/>
                    <measurement group_id="O2" value="-25.67" lower_limit="-42.901" upper_limit="-7.909"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8</title>
        <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8</title>
          <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-42.92" lower_limit="-65.580" upper_limit="-23.080"/>
                    <measurement group_id="O2" value="-31.95" lower_limit="-47.299" upper_limit="-13.978"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12</title>
        <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12</title>
          <description>The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.73" lower_limit="-67.719" upper_limit="-8.696"/>
                    <measurement group_id="O2" value="-32.60" lower_limit="-49.823" upper_limit="-12.574"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Area of Allodynia - Cohort 1 - Week 2</title>
        <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Area of Allodynia - Cohort 1 - Week 2</title>
          <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-40.06" lower_limit="-89.750" upper_limit="-12.158"/>
                    <measurement group_id="O2" value="-14.42" lower_limit="-34.431" upper_limit="23.824"/>
                    <measurement group_id="O3" value="-52.73" lower_limit="-67.258" upper_limit="-24.248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Area of Allodynia - Cohort 1 - Week 4</title>
        <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Area of Allodynia - Cohort 1 - Week 4</title>
          <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-54.12" lower_limit="-118.867" upper_limit="-19.566"/>
                    <measurement group_id="O2" value="-23.07" lower_limit="-41.985" upper_limit="19.468"/>
                    <measurement group_id="O3" value="-58.14" lower_limit="-70.452" upper_limit="-26.048"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Area of Allodynia - Cohort 1 - Week 8</title>
        <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Area of Allodynia - Cohort 1 - Week 8</title>
          <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-74.46" lower_limit="-136.541" upper_limit="-43.526"/>
                    <measurement group_id="O2" value="-50.47" lower_limit="-75.433" upper_limit="-4.124"/>
                    <measurement group_id="O3" value="-71.54" lower_limit="-85.155" upper_limit="-37.104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Area of Allodynia - Cohort 1 - Week 12</title>
        <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Area of Allodynia - Cohort 1 - Week 12</title>
          <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-67.71" lower_limit="-130.695" upper_limit="-35.611"/>
                    <measurement group_id="O2" value="-39.96" lower_limit="-62.646" upper_limit="8.446"/>
                    <measurement group_id="O3" value="-70.46" lower_limit="-92.167" upper_limit="-29.970"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Area of Allodynia - Cohort 2 - Week 2</title>
        <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Area of Allodynia - Cohort 2 - Week 2</title>
          <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.66" lower_limit="-59.461" upper_limit="-0.328"/>
                    <measurement group_id="O2" value="-60.71" lower_limit="-98.564" upper_limit="-36.369"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Area of Allodynia - Cohort 2 - Week 4</title>
        <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Area of Allodynia - Cohort 2 - Week 4</title>
          <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-54.33" lower_limit="-72.041" upper_limit="-13.677"/>
                    <measurement group_id="O2" value="-69.39" lower_limit="-116.234" upper_limit="-45.112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Area of Allodynia - Cohort 2 - Week 8</title>
        <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Area of Allodynia - Cohort 2 - Week 8</title>
          <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-78.78" lower_limit="-99.958" upper_limit="-43.748"/>
                    <measurement group_id="O2" value="-75.58" lower_limit="-113.401" upper_limit="-50.634"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Area of Allodynia - Cohort 2 - Week 12</title>
        <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Area of Allodynia - Cohort 2 - Week 12</title>
          <description>The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
          <units>Square Centimeters (cm^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-77.98" lower_limit="-99.148" upper_limit="-36.515"/>
                    <measurement group_id="O2" value="-79.99" lower_limit="-129.775" upper_limit="-49.428"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2</title>
        <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2</title>
          <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.4" lower_limit="-25.67" upper_limit="-10.68"/>
                    <measurement group_id="O2" value="-21.2" lower_limit="-30.01" upper_limit="-10.09"/>
                    <measurement group_id="O3" value="-15.3" lower_limit="-22.76" upper_limit="-7.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4</title>
        <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4</title>
          <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.9" lower_limit="-29.67" upper_limit="-15.57"/>
                    <measurement group_id="O2" value="-20.5" lower_limit="-28.34" upper_limit="-11.34"/>
                    <measurement group_id="O3" value="-12.3" lower_limit="-19.02" upper_limit="-5.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8</title>
        <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8</title>
          <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.7" lower_limit="-31.18" upper_limit="-15.80"/>
                    <measurement group_id="O2" value="-24.8" lower_limit="-34.73" upper_limit="-14.45"/>
                    <measurement group_id="O3" value="-19.4" lower_limit="-27.27" upper_limit="-10.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12</title>
        <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 65µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>AGN 214868 32.5µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12</title>
          <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
          <population>The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.2" lower_limit="-27.51" upper_limit="-12.14"/>
                    <measurement group_id="O2" value="-21.6" lower_limit="-33.46" upper_limit="-9.41"/>
                    <measurement group_id="O3" value="-21.5" lower_limit="-28.99" upper_limit="-12.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2</title>
        <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2</title>
          <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.0" lower_limit="-26.102" upper_limit="-11.030"/>
                    <measurement group_id="O2" value="-16.2" lower_limit="-23.400" upper_limit="-9.691"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4</title>
        <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4</title>
          <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.6" lower_limit="-27.941" upper_limit="-10.867"/>
                    <measurement group_id="O2" value="-20.5" lower_limit="-29.487" upper_limit="-13.640"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8</title>
        <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8</title>
          <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.7" lower_limit="-35.924" upper_limit="-21.285"/>
                    <measurement group_id="O2" value="-19.7" lower_limit="-27.721" upper_limit="-11.895"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12</title>
        <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>AGN 214868 130µg</title>
            <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12</title>
          <description>Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.</description>
          <population>The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.9" lower_limit="-37.750" upper_limit="-16.548"/>
                    <measurement group_id="O2" value="-19.1" lower_limit="-26.996" upper_limit="-10.612"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>AGN 214868 130µg</title>
          <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
        </group>
        <group group_id="E2">
          <title>AGN 214868 65µg</title>
          <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
        </group>
        <group group_id="E3">
          <title>AGN 214868 32.5µg</title>
          <description>Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 18.1">Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Labyrinthitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fractured sacrum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Pubis fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Urethral injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Joint crepitation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Thalamic infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5.0</frequency_threshold>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="30" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="123"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="123"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head</name_or_title>
      <organization>Allergan plc</organization>
      <phone>714-246-4500</phone>
      <email>clinicaltrials@allergan.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01678924
org study id: 214868-007
secondary id: 2012-002240-24
nct id: NCT01678924
lead sponsor: 
has dmc: Yes
This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia
      (PHN).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Average Pain Intensity Score - Cohort 1
time frame: Baseline to Week 12
description: The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. Patients used the 11-point Likert scale, with anchors at 0 = "no pain" and 10 = "pain as bad as you can imagine" Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.
measure: Change From Baseline in Average Pain Intensity Score - Cohort 2
time frame: Baseline to Week 12
description: The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. patients used the 11-point Likert scale, with anchors at 0 = "no pain" and 10 = "pain as bad as you can imagine" Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1
time frame: Baseline to Week 1
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2
time frame: Baseline to Week 2
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3
time frame: Baseline to Week 3
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4
time frame: Baseline to Week 4
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease), and in 10% increments, up to 100% improvement, in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5
time frame: Baseline to Week 5
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6
time frame: Baseline to Week 6
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7
time frame: Baseline to Week 7
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8
time frame: Baseline to Week 8
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9
time frame: Baseline to Week 9
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10
time frame: Baseline to Week 10
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11
time frame: Baseline to Week 11
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12
time frame: Baseline to Week 12
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1
time frame: Baseline to Week 1
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2
time frame: Baseline to Week 2
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3
time frame: Baseline to Week 3
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4
time frame: Baseline to Week 4
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5
time frame: Baseline to Week 5
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6
time frame: Baseline to Week 6
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7
time frame: Baseline to Week 7
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8
time frame: Baseline to Week 8
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9
time frame: Baseline to Week 9
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10
time frame: Baseline to Week 10
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11
time frame: Baseline to Week 11
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12
time frame: Baseline to Week 12
description: Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2
time frame: Baseline to Week 2
description: The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient and that the patient was asked to circle their MASP on with a black marker. Areas of pain were quantified at a central reading center.
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4
time frame: Baseline to Week 4
description: The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8
time frame: Baseline to Week 8
description: The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12
time frame: Baseline to Week 12
description: The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2
time frame: Baseline to Week 2
description: The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4
time frame: Baseline to Week 4
description: The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8
time frame: Baseline to Week 8
description: The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12
time frame: Baseline to Week 12
description: The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.
measure: Change From Baseline in Area of Allodynia - Cohort 1 - Week 2
time frame: Baseline to Week 2
description: The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
measure: Change From Baseline in Area of Allodynia - Cohort 1 - Week 4
time frame: Baseline to Week 4
description: The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
measure: Change From Baseline in Area of Allodynia - Cohort 1 - Week 8
time frame: Baseline to Week 8
description: The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
measure: Change From Baseline in Area of Allodynia - Cohort 1 - Week 12
time frame: Baseline to Week 12
description: The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
measure: Change From Baseline in Area of Allodynia - Cohort 2 - Week 2
time frame: Baseline to Week 2
description: The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
measure: Change From Baseline in Area of Allodynia - Cohort 2 - Week 4
time frame: Baseline to Week 4
description: The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
measure: Change From Baseline in Area of Allodynia - Cohort 2 - Week 8
time frame: Baseline to Week 8
description: The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
measure: Change From Baseline in Area of Allodynia - Cohort 2 - Week 12
time frame: Baseline to Week 12
description: The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2
time frame: Baseline to Week 2
description: Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4
time frame: Baseline to Week 4
description: Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8
time frame: Baseline to Week 8
description: Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12
time frame: Baseline to Week 12
description: Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2
time frame: Baseline to Week 2
description: Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4
time frame: Baseline to Week 4
description: Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8
time frame: Baseline to Week 8
description: Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12
time frame: Baseline to Week 12
description: Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
arm group label: AGN-214868 Dose 1
arm group type: Experimental
description: AGN-214868 Dose 1 given as injections into the area of pain on Day 1.
arm group label: AGN-214868 Dose 2
arm group type: Experimental
description: AGN-214868 Dose 2 given as injections into the area of pain on Day 1.
arm group label: AGN-214868 Placebo (Vehicle)
arm group type: Placebo Comparator
description: AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
arm group label: AGN-214868 Dose 3
arm group type: Experimental
description: AGN-214868 Dose 3 given as injections into the area of pain on Day 1.
intervention type: Drug
intervention name: AGN-214868
description: AGN-214868 given as injections into the area of pain on Day 1.
arm group label: AGN-214868 Dose 1
arm group label: AGN-214868 Dose 2
arm group label: AGN-214868 Dose 3
intervention type: Drug
intervention name: AGN-214868 Placebo (Vehicle)
description: AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
arm group label: AGN-214868 Placebo (Vehicle)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
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country: Austria
country: Germany
country: Poland
country: United States
country: Australia
country: Czech Republic
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Neuralgia, Postherpetic
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