<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/NCT01706003</url>
  </required_header>
  <id_info>
    <org_study_id>MK0974-071-00</org_study_id>
    <secondary_id>MERCK</secondary_id>
    <nct_id>NCT01706003</nct_id>
  </id_info>
  <brief_title>The Utility of Telemedicine in the Management of Migraine</brief_title>
  <official_title>The Utility of Telemedicine in the Management of Migraine: A Pilot Study :MK0974-071-00</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients will be randomly assigned to receive their follow-up care via telemedicine or&#xD;
      in-office visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining informed consent, patients will be randomly assigned to receive their&#xD;
      follow-up care via telemedicine or in-office visits. All subjects will complete a MIDAS&#xD;
      questionnaire and allodynia questionnaire at their initial visit. Follow-up visits will be&#xD;
      scheduled at 4-6 weeks, 3, 6, 9 and 12 months. In-person follow-up visits will be conducted&#xD;
      in the standard fashion of the current physician's practice, with the initial intake&#xD;
      conducted by an ophthalmic technician or resident, followed by the physician visit.&#xD;
      Telemedicine visits will be conducted by the physician and recorded. Similar information will&#xD;
      be gathered in both groups including: current medications, interim medical and headache&#xD;
      history (including visits to the ED or hospitalizations for headache), description of&#xD;
      headache, response to treatment (including adverse reactions), allergies, blood pressure and&#xD;
      weight. Subjects randomized to telemedicine will be asked to have their blood pressure and&#xD;
      weight measured within 5 days of their telemedicine session at a location convenient to them.&#xD;
      We will record the length of each visit. Subjects in the in-person group, will be queried&#xD;
      about travel time, and the total amount of time for the visit, and any activities missed to&#xD;
      attend the visit. We will also ask about other costs associated with attending the office&#xD;
      visit, such as child care.&#xD;
&#xD;
      At the one-year follow-up visit, subjects will complete the MIDAS, allodynia questionnaire,&#xD;
      Modified Group Health Association of America's Consumer Satisfaction scale, and have the&#xD;
      opportunity to express their views on the aspect of care received in a semi-structured&#xD;
      interview. The follow-up questionnaires may be completed on line (telemedicine group,&#xD;
      optional for in-person group) or on paper (in-person group). Headache diaries will be&#xD;
      provided on line or may be done on paper, a smartphone, or a computer program of the&#xD;
      subject's choosing.&#xD;
&#xD;
      All subjects will be able to access the physician by telephone, using MyChart, or with&#xD;
      additional non-study visits as needed.&#xD;
&#xD;
      Subjects will be responsible for the cost of the medications, treatments prescribed, and&#xD;
      laboratory monitoring needed for their condition.&#xD;
&#xD;
      Support staff will be available to help set up the video system for subjects assigned to the&#xD;
      telemedicine group who are in need of assistance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice</measure>
    <time_frame>One Year</time_frame>
    <description>Percentage of completed scheduled study visits for each group.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Migraine Headaches</condition>
  <arm_group>
    <arm_group_label>Telemedicine Group</arm_group_label>
    <description>People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In-Office Group</arm_group_label>
    <description>People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients must be diagnosed with Migraine Headaches&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:• Ages 18 - 89 years&#xD;
&#xD;
          -  Diagnosis of migraine with or without aura, menstrual migraine, hemiplegic migraine&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Able, in the opinion of the investigator, to reliably perform all aspects of the study&#xD;
&#xD;
          -  Ownership of or access to a computer and high speed internet&#xD;
&#xD;
        Criteria for Exclusion of Subjects:&#xD;
&#xD;
          -  Age less than 18 years&#xD;
&#xD;
          -  Headache type is not migraine&#xD;
&#xD;
          -  No ownership or access to a computer or high speed internet&#xD;
&#xD;
          -  Unfamiliar with basic computer operations or uncomfortable using a computer&#xD;
&#xD;
          -  Unwilling to participate&#xD;
&#xD;
          -  Unable to read English (because of assessment tools)&#xD;
&#xD;
          -  History of another medical, psychiatric, social or behavioral problem that, in the&#xD;
             opinion of the investigator, makes it unlikely that they will be able to complete the&#xD;
             study activities. Questions regarding mood and anxiety are asked of all patients as&#xD;
             part of their initial evaluation for headache.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deborah Friedman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universit of Texas Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>June 11, 2019</results_first_submitted>
  <results_first_submitted_qc>September 29, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 25, 2019</results_first_posted>
  <last_update_submitted>September 29, 2019</last_update_submitted>
  <last_update_submitted_qc>September 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Deborah Friedman</investigator_full_name>
    <investigator_title>Primary Investigator, MD, Neurology and Neurotheraputics</investigator_title>
  </responsible_party>
  <keyword>Migraine</keyword>
  <keyword>Headaches</keyword>
  <keyword>Telemedicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 28, 2012</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT01706003/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>In-Office Group</title>
          <description>People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches</description>
        </group>
        <group group_id="P2">
          <title>Telemedicine Group</title>
          <description>People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not scheduled</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>In-Office Group</title>
          <description>People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches</description>
        </group>
        <group group_id="B2">
          <title>Telemedicine Group</title>
          <description>People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches</description>
        </group>
        <group group_id="B3">
          <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="23"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="45"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="23"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="23"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="23"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Migraine Disability Assessment Score (MIDAS)</title>
          <description>The Migraine Disability Assessment Score (MIDAS) has a scale range of 0-270. Lower values represents a better outcome, higher values represents a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="23"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.5" lower_limit="3" upper_limit="161"/>
                    <measurement group_id="B2" value="65" lower_limit="11" upper_limit="192"/>
                    <measurement group_id="B3" value="47.9" lower_limit="3" upper_limit="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice</title>
        <description>Percentage of completed scheduled study visits for each group.</description>
        <time_frame>One Year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In-Office Group</title>
            <description>People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches</description>
          </group>
          <group group_id="O2">
            <title>Telemedicine Group</title>
            <description>People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches</description>
          </group>
        </group_list>
        <measure>
          <title>Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice</title>
          <description>Percentage of completed scheduled study visits for each group.</description>
          <units>percentage of scheduled appointments</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="92.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>In-Office Group</title>
          <description>People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches</description>
        </group>
        <group group_id="E2">
          <title>Telemedicine Group</title>
          <description>People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital admission</sub_title>
                <description>Hospitalized for headache treatment as part of routine clinical care</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Deborah I. Friedman, MD, MPH, Professor of Neurology and Neurotherapeutics and Ophthalmology</name_or_title>
      <organization>UT Southwestern Medical Center</organization>
      <phone>2146483517</phone>
      <email>Deborah.Friedman@utsouthwestern.edu</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/NCT01706003
org study id: MK0974-071-00
secondary id: MERCK
nct id: NCT01706003
lead sponsor: 
collaborator: 
has dmc: No
Patients will be randomly assigned to receive their follow-up care via telemedicine or
      in-office visits.
After obtaining informed consent, patients will be randomly assigned to receive their
      follow-up care via telemedicine or in-office visits. All subjects will complete a MIDAS
      questionnaire and allodynia questionnaire at their initial visit. Follow-up visits will be
      scheduled at 4-6 weeks, 3, 6, 9 and 12 months. In-person follow-up visits will be conducted
      in the standard fashion of the current physician's practice, with the initial intake
      conducted by an ophthalmic technician or resident, followed by the physician visit.
      Telemedicine visits will be conducted by the physician and recorded. Similar information will
      be gathered in both groups including: current medications, interim medical and headache
      history (including visits to the ED or hospitalizations for headache), description of
      headache, response to treatment (including adverse reactions), allergies, blood pressure and
      weight. Subjects randomized to telemedicine will be asked to have their blood pressure and
      weight measured within 5 days of their telemedicine session at a location convenient to them.
      We will record the length of each visit. Subjects in the in-person group, will be queried
      about travel time, and the total amount of time for the visit, and any activities missed to
      attend the visit. We will also ask about other costs associated with attending the office
      visit, such as child care.

      At the one-year follow-up visit, subjects will complete the MIDAS, allodynia questionnaire,
      Modified Group Health Association of America's Consumer Satisfaction scale, and have the
      opportunity to express their views on the aspect of care received in a semi-structured
      interview. The follow-up questionnaires may be completed on line (telemedicine group,
      optional for in-person group) or on paper (in-person group). Headache diaries will be
      provided on line or may be done on paper, a smartphone, or a computer program of the
      subject's choosing.

      All subjects will be able to access the physician by telephone, using MyChart, or with
      additional non-study visits as needed.

      Subjects will be responsible for the cost of the medications, treatments prescribed, and
      laboratory monitoring needed for their condition.

      Support staff will be available to help set up the video system for subjects assigned to the
      telemedicine group who are in need of assistance.
observational model: Ecologic or Community
time perspective: Prospective
measure: Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice
time frame: One Year
description: Percentage of completed scheduled study visits for each group.
arm group label: Telemedicine Group
description: People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches
arm group label: In-Office Group
description: People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Deborah Friedman, MD
role: Principal Investigator
affiliation: University of Texas Southwestern Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Deborah Friedman
investigator title: Primary Investigator, MD, Neurology and Neurotheraputics
mesh term: Migraine Disorders
mesh term: Headache
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 