<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/NCT02974114</url>
  </required_header>
  <id_info>
    <org_study_id>204503</org_study_id>
    <nct_id>NCT02974114</nct_id>
  </id_info>
  <brief_title>Exploratory Study to Investigate Cognition Function and Mobility in Individuals With Pain</brief_title>
  <official_title>Assessment of Cognitive Function and Mobility in Individuals With Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      This parallel, assessor blind, placebo-controlled, stratified, randomized study will&#xD;
      investigate the effects of everyday pain on cognition and mobility in otherwise healthy&#xD;
      individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consisted of 3 visits. Visit 1 (Day1, Screening), minimum (min) of 7 days and&#xD;
      maximum (max) of 28 days gap followed by Visit 2 (Day 2, pain-state assessment), a recovery&#xD;
      period of min of 2 days and max of 30 days followed by Visit 3 (Day 3, pain-free assessment).&#xD;
      Participants received treatment once only on Visit 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">October 31, 2016</start_date>
  <completion_date type="Actual">February 6, 2017</completion_date>
  <primary_completion_date type="Actual">February 6, 2017</primary_completion_date>
  <phase>Phase 4</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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Pain Free State (Day 3) in Error Adjusted Simple Reaction Time (SRT) in the Pain State (Day 2)</measure>
    <time_frame>At Day 2 (pre and post-treatment) and Day 3 of the study</time_frame>
    <description>Error adjusted SRT was one of the main outcomes of the Axon Sports Priming Application. The Axon Sports Priming Application is a computerized test performed on a tablet device that measures cognitive performance, namely psychomotor speed. Axon sports test assessment included 1. Pain-state assessment performed at Visit 2 (Day 2 pre-treatment assessment and post-treatment assessment 1hour [hr] ± 15 minutes [mins] post-dosing) and 2. Pain-free assessment performed at Visit 3 (Day 3).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Pain-free State (Day 3) in Reaction Time in the Pain State (Day 2)</measure>
    <time_frame>At Day 2 (pre and post-treatment) and Day 3 of the study</time_frame>
    <description>The reaction time of five-choice reaction time task (provided by Cambridge Cognition) was measured. In five-choice reaction time task, all the participants hold down a button at the bottom of the screen till a yellow spot appears in one of the five circles at the top of the screen. Participants then released the button and touch inside of the circle where the yellow spot appeared as quickly as they can. The median duration, between the onset of the stimulus and the release of the button, was recorded as reaction time. Calculated for correct, assessed trials where the stimulus appeared in any one of five locations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Pain-free State (Day 3) in Number of One Touch Stockings (OTS) of Cambridge Assessment Problems (on Which the First Box Choice Made Was Correct) in the Pain State (Day 2)</measure>
    <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
    <description>OTS was a measure of executive function and takes approximately 10 minutes to complete. The participant was shown two displays containing three coloured balls. The displays were presented in such a way that they can easily be perceived as stacks of coloured balls held in stockings or socks suspended from a beam. There was a row of numbered boxes along the bottom of the screen. The test administrator first demonstrated to the participant how to use the balls in the lower display to copy the pattern in the upper display, and completed one demonstration problem, where the solution requires one move. The participant then completed three further problems, one each of two moves, three moves, and four moves. Next, the participant was shown further problems, and participants worked out in their head how many moves the solutions to these problems required, and then touch the appropriate box at the bottom of the screen to indicate their response.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Pain-free State (Day 3) in Attention Switching Task (AST) Congruency Cost in the Pain State (Day 2)</measure>
    <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
    <description>AST was a measure of executive attention. The test displayed an arrow which can appear on either side of the screen and can point in either direction. Each trial displayed a cue at the top of the screen that indicates whether to press the right or left button. Some trials displayed congruent stimuli (e.g. arrow on the right side of the screen pointing to the right) whereas other trials display incongruent stimuli which require a higher cognitive demand (e.g. arrow on the right side of the screen pointing to the left). The AST congruency cost was the difference between the median latencies of response (from stimulus appearance to button press) on the trials that were congruent versus the trials that were incongruent. It was calculated by subtracting the median of congruent from incongruent latency. A positive score indicated response was faster on congruent trials and a negative score indicated response was faster on incongruent trials.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Pain-free State (Day 3) in Spatial Working Memory (SWM) Between Errors in the Pain State (Day 2)</measure>
    <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
    <description>SWM task was a measure of working memory. The task involved number of coloured squares (boxes) being shown on the screen. The aim of this test was to find one blue token in the boxes shown to the participants by process of elimination and used these to fill up an empty column on the right-hand side of the screen. The number of boxes gradually increased up to a maximum of eight boxes to search and the colour and position of the boxes changed from trial to trial. SWM between errors was defined as times the participant revisited a box in which a token has previously been found. This was calculated for trials of four, six and eight tokens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Pain-free State (Day 3) in Rapid Visual Information Processing A Prime (RVPA) in the Pain State (Day 2)</measure>
    <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
    <description>RVP task was measures of attention. A white box appeared in the centre of the computer screen, inside which digits, from 2 to 9, appeared in a pseudo-random order, at the rate of 100 digits per minute. Participants were requested to detect target sequences of digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the press pad. The RVPA (A prime) was the signal detection measure of sensitivity to the target, regardless of response tendency (the expected range will be 0.00 to 1.00; bad to good). RVP metric was a measure of how good the subject was at detecting target sequences.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Pain-free State (Day 3) in Grip Force in Pain State (Day 2)</measure>
    <time_frame>At Day 2 (pre and post-treatment) and Day 3 of the study</time_frame>
    <description>This task was a measure of grip strength. The participant held the dynamometer in their dominant hand and the arm was swung from above the head to by the side of the body. If the dominant arm or hand was painful then the non-dominant hand was used. The participant was instructed to assert maximum effort during the squeezing motion and maintain it for about 4 seconds using a metronome. Participant conducted the movement 4-times (1 practice effort and 3 test efforts) and there was a 1-minute recovery period between each effort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Pain-free State (Day 3) in Time to Standing in Pain State (Day 2)</measure>
    <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
    <description>Time to standing provides a simple assessment of physical mobility. From a seated position with arms crossed so that the right hand is placed on the left shoulder and the left hand on the right shoulder, participants stood to a fully erect stature in as short a time as possible. Time to standing recorded which was measured using a stopwatch. Participants conducted the same movement 3-times continuously as a practice effort and 5-times continuously as a test effort at each visit. There was a 1-minute rest between the practice and test effort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Pain-free State (Day 3) in Ground Reaction Force (GRF) in Pain State (Day 2)</measure>
    <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
    <description>From a seated position with arms crossed so that the right hand is placed on the left shoulder and the left hand on the right shoulder, participants stood to a fully erect stature in as short a time as possible. Participants conducted the same movement 3-times continuously as a practice effort and 5-times continuously as a test effort at each visit. There was a 1-minute rest between the practice and test effort. GRF was measured during the movement analyzed using a force plate interfaced with a computer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Pain-free State (Day 3) in Contact Phase in Pain State (Day 2)</measure>
    <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
    <description>Participants performed a walking assessment in comfortable walking shoes to measure gait parameter contact phase. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Pain-free State (Day 3) in Stride Length in Pain State (Day 2)</measure>
    <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
    <description>Participants performed a walking assessment in comfortable walking shoes to measure gait parameter stride length. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Pain-free State (Day 3) in Walking Speed in Pain State (Day 2)</measure>
    <time_frame>At Day 2 (pre and post-treatment) and Day 3</time_frame>
    <description>Participants performed a walking assessment in comfortable walking shoes to measure gait parameter walking speed over 5-10m for each foot. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Paracetamol and caffeine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered test product (containing 500 mg paracetamol and 65 mg caffeine). Two tablets will be taken orally once with 200 mL (milliliters) of water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paracetamol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered test product (containing 500 mg paracetamol). Two tablets will be taken orally once with 200 mL of water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be administered reference product (placebo to match Paracetamol 665mg sustained release tablets). Two tablets will be taken orally once with 200 mL of water.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol and caffeine</intervention_name>
    <description>Test product containing 500 mg paracetamol and 65 mg caffeine</description>
    <arm_group_label>Paracetamol and caffeine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol</intervention_name>
    <description>Test product containing 500 mg paracetamol</description>
    <arm_group_label>Paracetamol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo to match paracetamol 665mg sustained release tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Demonstrates understanding of the study procedures, restrictions and willingness to&#xD;
             participate as evidenced by voluntary written informed consent and has received a&#xD;
             signed and dated copy of the informed consent form.&#xD;
&#xD;
          -  Aged between 18-65 years.&#xD;
&#xD;
          -  Participant is male or female.&#xD;
&#xD;
          -  Understands and is willing, able and likely to comply with all study procedures and&#xD;
             restrictions.&#xD;
&#xD;
          -  Adequately completes cognition and mobility familiarisation tasks in the opinion of&#xD;
             the investigator.&#xD;
&#xD;
          -  Good general and mental health with, in the opinion of the investigator or medically&#xD;
             qualified designee: No clinically significant and relevant abnormalities in medical&#xD;
             history or upon physical examination; absence of any condition that might impact on&#xD;
             the participant's safety or wellbeing or affect the individual's ability to understand&#xD;
             and follow study procedures and requirements; BMI &gt;18.5 and &lt;30 kg/m2&#xD;
&#xD;
          -  VISIT 1 ONLY - Has experienced a minimum of two recurrent, acute pain episodes within&#xD;
             the past 3 months or is currently suffering from a flare up episode of recurrent,&#xD;
             acute pain; VISIT 2 ONLY - A score ≥5 to question 6 (rated on scale 0-10) on the Brief&#xD;
             Pain Inventory - Short Form and participants presenting with only one of the following&#xD;
             pain types: Joint (Knee, Hip); Back; Headache; Period.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Women who are pregnant (Visit 1), women of child bearing potential who test positive&#xD;
             on a urine pregnancy test (Visit 1 or Visit 2), females of non-child bearing potential&#xD;
             will not be required to complete urinary pregnancy test, post-menopausal females not&#xD;
             requiring a pregnancy test will be defined as: Age ≥ 50 years with spontaneous&#xD;
             cessation of menses for 12 or more months or age &lt; 55 years and spontaneous menses&#xD;
             within the past 1 year, but currently amenorrheic.&#xD;
&#xD;
          -  Women who are currently breast-feeding.&#xD;
&#xD;
          -  In the opinion of the medical designee, participant suffers from medical condition(s)&#xD;
             that may be aggravated due to testing procedures or may impact the interpretation or&#xD;
             integrity of data. Conditions related to renal, hepatic, respiratory, blood, immune&#xD;
             systems or heart dysfunction will be considered.&#xD;
&#xD;
          -  Participant is colour blind.&#xD;
&#xD;
          -  Current (within 14 days of the start of the study) or regular use of any prescription,&#xD;
             over-the-counter (OTC), herbal medicine unless the medication has been approved by the&#xD;
             study physician. OTC analgesics for pain relief and vitamin supplements are permitted&#xD;
             only until 48 hours prior to study visits; Current or in the 30 days prior to dosing&#xD;
             use of any drug, food, herbal product, or dietary supplement known to induce or&#xD;
             inhibit hepatic drug metabolism (e.g. barbiturates, theophylline, cimetidine, or&#xD;
             erythromycin) ;Use of analgesics and anti-inflammatory drugs 48 hours prior to dosing&#xD;
             at Visit 2; Known to be taking any other medication which could counteract with&#xD;
             paracetamol and/or caffeine; Current or past use of anti-depressants or psychoactive&#xD;
             drugs within the previous 2-years.&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely&#xD;
             related compounds) or any of their stated ingredients.&#xD;
&#xD;
          -  Positive breath alcohol test at Visit 2 and positive urine drugs of abuse test at&#xD;
             Visit 2.&#xD;
&#xD;
          -  Participation in another clinical study (including cosmetic studies) or receipt of an&#xD;
             investigational product within 7 days of the screening visit or previous participation&#xD;
             and randomization in this study.&#xD;
&#xD;
          -  Participant has excessive frequent caffeine intake equivalent to 6 cups of brewed&#xD;
             coffee or 12 cups of tea per day; Unwilling to abstain from any caffeine products from&#xD;
             4 hours prior to the visit on assessment days (Visit 2 and 3); Current Smoker (or&#xD;
             regular nicotine consumption): Participant smokes more than 3 cigarettes per day (or&#xD;
             equivalent for e-cigarettes, chewing tobacco or pipes). Investigator will ensure there&#xD;
             is no impact of withdrawal effect from those with nicotine dependence; Current Alcohol&#xD;
             Consumer: Participant consumes greater than 21 units of alcohol per week (male) and 14&#xD;
             units per week (female) (e.g. Spirit 25ml = 1 unit / AlcoPop 275ml = 1.5 unit / Bottle&#xD;
             of beer 330 ml = 1.7 unit / Glass of wine 175ml = 2.1 unit / Pint of beer 568 ml = 3&#xD;
             unit).&#xD;
&#xD;
          -  Members of the study site staff or members of their immediate family.&#xD;
&#xD;
          -  Any participant who in the opinion of the investigator should not take part in this&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brentford</city>
        <state>Middlesex</state>
        <zip>TW8 9DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 19, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <results_first_submitted>October 24, 2017</results_first_submitted>
  <results_first_submitted_qc>June 15, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 28, 2018</results_first_posted>
  <last_update_submitted>June 15, 2018</last_update_submitted>
  <last_update_submitted_qc>June 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Caffeine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 7, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT02974114/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT02974114/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All participants were recruited at a single center from the United Kingdom.</recruitment_details>
      <pre_assignment_details>A Total of 54 participants were screened, out of which 21 participants were randomized to the study, 5 participants were screening failure, 1 participant withdrew consent and 27 participants were not randomized due to other reasons (not specified).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Paracetamol and Caffeine</title>
          <description>All the participants in this arm received test product (containing 500 milligram [mg] of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 milliliters (mL) of water.</description>
        </group>
        <group group_id="P2">
          <title>Paracetamol</title>
          <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets orally once with 200 mL of water.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets orally once with 200 mL of water.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other (Not specified)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Paracetamol and Caffeine</title>
          <description>All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets orally once with 200 mL of water.</description>
        </group>
        <group group_id="B2">
          <title>Paracetamol</title>
          <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets orally once with 200 mL of water.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets orally once with 200 mL of water.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="21"/>
          </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="27.8" spread="4.83"/>
                    <measurement group_id="B2" value="30.0" spread="9.45"/>
                    <measurement group_id="B3" value="40.0" spread="15.87"/>
                    <measurement group_id="B4" value="33.2" spread="12.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Pain Free State (Day 3) in Error Adjusted Simple Reaction Time (SRT) in the Pain State (Day 2)</title>
        <description>Error adjusted SRT was one of the main outcomes of the Axon Sports Priming Application. The Axon Sports Priming Application is a computerized test performed on a tablet device that measures cognitive performance, namely psychomotor speed. Axon sports test assessment included 1. Pain-state assessment performed at Visit 2 (Day 2 pre-treatment assessment and post-treatment assessment 1hour [hr] ± 15 minutes [mins] post-dosing) and 2. Pain-free assessment performed at Visit 3 (Day 3).</description>
        <time_frame>At Day 2 (pre and post-treatment) and Day 3 of the study</time_frame>
        <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol and Caffeine</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pain Free State (Day 3) in Error Adjusted Simple Reaction Time (SRT) in the Pain State (Day 2)</title>
          <description>Error adjusted SRT was one of the main outcomes of the Axon Sports Priming Application. The Axon Sports Priming Application is a computerized test performed on a tablet device that measures cognitive performance, namely psychomotor speed. Axon sports test assessment included 1. Pain-state assessment performed at Visit 2 (Day 2 pre-treatment assessment and post-treatment assessment 1hour [hr] ± 15 minutes [mins] post-dosing) and 2. Pain-free assessment performed at Visit 3 (Day 3).</description>
          <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
          <units>milliseconds (msec)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from pain-free state at Day 2 pre-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" lower_limit="0.0" upper_limit="0.2"/>
                    <measurement group_id="O2" value="0.07" lower_limit="0.0" upper_limit="0.8"/>
                    <measurement group_id="O3" value="0.06" lower_limit="0.0" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from pain-free state at Day2 post-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" lower_limit="0.0" upper_limit="0.4"/>
                    <measurement group_id="O2" value="0.01" lower_limit="0.0" upper_limit="0.3"/>
                    <measurement group_id="O3" value="0.00" lower_limit="-0.2" upper_limit="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Pain-free State (Day 3) in Reaction Time in the Pain State (Day 2)</title>
        <description>The reaction time of five-choice reaction time task (provided by Cambridge Cognition) was measured. In five-choice reaction time task, all the participants hold down a button at the bottom of the screen till a yellow spot appears in one of the five circles at the top of the screen. Participants then released the button and touch inside of the circle where the yellow spot appeared as quickly as they can. The median duration, between the onset of the stimulus and the release of the button, was recorded as reaction time. Calculated for correct, assessed trials where the stimulus appeared in any one of five locations.</description>
        <time_frame>At Day 2 (pre and post-treatment) and Day 3 of the study</time_frame>
        <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol and Caffeine</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pain-free State (Day 3) in Reaction Time in the Pain State (Day 2)</title>
          <description>The reaction time of five-choice reaction time task (provided by Cambridge Cognition) was measured. In five-choice reaction time task, all the participants hold down a button at the bottom of the screen till a yellow spot appears in one of the five circles at the top of the screen. Participants then released the button and touch inside of the circle where the yellow spot appeared as quickly as they can. The median duration, between the onset of the stimulus and the release of the button, was recorded as reaction time. Calculated for correct, assessed trials where the stimulus appeared in any one of five locations.</description>
          <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
          <units>msec</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from pain-free state at Day 2 pre-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="-17.5" upper_limit="36.0"/>
                    <measurement group_id="O2" value="-1.75" lower_limit="-41.0" upper_limit="170.5"/>
                    <measurement group_id="O3" value="-1.00" lower_limit="-6.5" upper_limit="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from pain-free state at Day2 post-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.75" lower_limit="-11.5" upper_limit="83.5"/>
                    <measurement group_id="O2" value="12.50" lower_limit="-65.5" upper_limit="26.0"/>
                    <measurement group_id="O3" value="-8.00" lower_limit="-28.0" upper_limit="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Pain-free State (Day 3) in Number of One Touch Stockings (OTS) of Cambridge Assessment Problems (on Which the First Box Choice Made Was Correct) in the Pain State (Day 2)</title>
        <description>OTS was a measure of executive function and takes approximately 10 minutes to complete. The participant was shown two displays containing three coloured balls. The displays were presented in such a way that they can easily be perceived as stacks of coloured balls held in stockings or socks suspended from a beam. There was a row of numbered boxes along the bottom of the screen. The test administrator first demonstrated to the participant how to use the balls in the lower display to copy the pattern in the upper display, and completed one demonstration problem, where the solution requires one move. The participant then completed three further problems, one each of two moves, three moves, and four moves. Next, the participant was shown further problems, and participants worked out in their head how many moves the solutions to these problems required, and then touch the appropriate box at the bottom of the screen to indicate their response.</description>
        <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
        <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol and Caffeine</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pain-free State (Day 3) in Number of One Touch Stockings (OTS) of Cambridge Assessment Problems (on Which the First Box Choice Made Was Correct) in the Pain State (Day 2)</title>
          <description>OTS was a measure of executive function and takes approximately 10 minutes to complete. The participant was shown two displays containing three coloured balls. The displays were presented in such a way that they can easily be perceived as stacks of coloured balls held in stockings or socks suspended from a beam. There was a row of numbered boxes along the bottom of the screen. The test administrator first demonstrated to the participant how to use the balls in the lower display to copy the pattern in the upper display, and completed one demonstration problem, where the solution requires one move. The participant then completed three further problems, one each of two moves, three moves, and four moves. Next, the participant was shown further problems, and participants worked out in their head how many moves the solutions to these problems required, and then touch the appropriate box at the bottom of the screen to indicate their response.</description>
          <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
          <units>OTS of correct first box choice</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from pain-free state at Day 2 pre-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.67" spread="3.077"/>
                    <measurement group_id="O2" value="0.00" spread="1.095"/>
                    <measurement group_id="O3" value="-0.20" spread="1.789"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from pain-free state at Day2 post-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.83" spread="1.941"/>
                    <measurement group_id="O2" value="2.17" spread="1.835"/>
                    <measurement group_id="O3" value="-1.40" spread="2.702"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Pain-free State (Day 3) in Attention Switching Task (AST) Congruency Cost in the Pain State (Day 2)</title>
        <description>AST was a measure of executive attention. The test displayed an arrow which can appear on either side of the screen and can point in either direction. Each trial displayed a cue at the top of the screen that indicates whether to press the right or left button. Some trials displayed congruent stimuli (e.g. arrow on the right side of the screen pointing to the right) whereas other trials display incongruent stimuli which require a higher cognitive demand (e.g. arrow on the right side of the screen pointing to the left). The AST congruency cost was the difference between the median latencies of response (from stimulus appearance to button press) on the trials that were congruent versus the trials that were incongruent. It was calculated by subtracting the median of congruent from incongruent latency. A positive score indicated response was faster on congruent trials and a negative score indicated response was faster on incongruent trials.</description>
        <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
        <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol and Caffeine</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pain-free State (Day 3) in Attention Switching Task (AST) Congruency Cost in the Pain State (Day 2)</title>
          <description>AST was a measure of executive attention. The test displayed an arrow which can appear on either side of the screen and can point in either direction. Each trial displayed a cue at the top of the screen that indicates whether to press the right or left button. Some trials displayed congruent stimuli (e.g. arrow on the right side of the screen pointing to the right) whereas other trials display incongruent stimuli which require a higher cognitive demand (e.g. arrow on the right side of the screen pointing to the left). The AST congruency cost was the difference between the median latencies of response (from stimulus appearance to button press) on the trials that were congruent versus the trials that were incongruent. It was calculated by subtracting the median of congruent from incongruent latency. A positive score indicated response was faster on congruent trials and a negative score indicated response was faster on incongruent trials.</description>
          <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
          <units>msec</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from pain-free state at Day 2 pre-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.25" lower_limit="-44.5" upper_limit="46.5"/>
                    <measurement group_id="O2" value="46.25" lower_limit="-22.5" upper_limit="99.5"/>
                    <measurement group_id="O3" value="2.50" lower_limit="-4.0" upper_limit="113.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from pain-free state at Day2 post-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.25" lower_limit="-44.0" upper_limit="43.5"/>
                    <measurement group_id="O2" value="23.00" lower_limit="-5.0" upper_limit="104.0"/>
                    <measurement group_id="O3" value="22.50" lower_limit="-171.5" upper_limit="113.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Pain-free State (Day 3) in Spatial Working Memory (SWM) Between Errors in the Pain State (Day 2)</title>
        <description>SWM task was a measure of working memory. The task involved number of coloured squares (boxes) being shown on the screen. The aim of this test was to find one blue token in the boxes shown to the participants by process of elimination and used these to fill up an empty column on the right-hand side of the screen. The number of boxes gradually increased up to a maximum of eight boxes to search and the colour and position of the boxes changed from trial to trial. SWM between errors was defined as times the participant revisited a box in which a token has previously been found. This was calculated for trials of four, six and eight tokens.</description>
        <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
        <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol and Caffeine</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pain-free State (Day 3) in Spatial Working Memory (SWM) Between Errors in the Pain State (Day 2)</title>
          <description>SWM task was a measure of working memory. The task involved number of coloured squares (boxes) being shown on the screen. The aim of this test was to find one blue token in the boxes shown to the participants by process of elimination and used these to fill up an empty column on the right-hand side of the screen. The number of boxes gradually increased up to a maximum of eight boxes to search and the colour and position of the boxes changed from trial to trial. SWM between errors was defined as times the participant revisited a box in which a token has previously been found. This was calculated for trials of four, six and eight tokens.</description>
          <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
          <units>SWM between errors</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from pain-free state at Day 2 pre-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.33" spread="18.747"/>
                    <measurement group_id="O2" value="25.17" spread="29.075"/>
                    <measurement group_id="O3" value="13.80" spread="23.994"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from pain-free state at Day2 post-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.83" spread="22.248"/>
                    <measurement group_id="O2" value="13.50" spread="23.193"/>
                    <measurement group_id="O3" value="-9.80" spread="32.920"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Pain-free State (Day 3) in Rapid Visual Information Processing A Prime (RVPA) in the Pain State (Day 2)</title>
        <description>RVP task was measures of attention. A white box appeared in the centre of the computer screen, inside which digits, from 2 to 9, appeared in a pseudo-random order, at the rate of 100 digits per minute. Participants were requested to detect target sequences of digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the press pad. The RVPA (A prime) was the signal detection measure of sensitivity to the target, regardless of response tendency (the expected range will be 0.00 to 1.00; bad to good). RVP metric was a measure of how good the subject was at detecting target sequences.</description>
        <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
        <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol and Caffeine</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pain-free State (Day 3) in Rapid Visual Information Processing A Prime (RVPA) in the Pain State (Day 2)</title>
          <description>RVP task was measures of attention. A white box appeared in the centre of the computer screen, inside which digits, from 2 to 9, appeared in a pseudo-random order, at the rate of 100 digits per minute. Participants were requested to detect target sequences of digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the press pad. The RVPA (A prime) was the signal detection measure of sensitivity to the target, regardless of response tendency (the expected range will be 0.00 to 1.00; bad to good). RVP metric was a measure of how good the subject was at detecting target sequences.</description>
          <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
          <units>msec</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from pain-free state at Day 2 pre-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" lower_limit="-0.1" upper_limit="0.0"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O3" value="-0.03" lower_limit="-0.1" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from pain-free state at Day2 post-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" lower_limit="-0.1" upper_limit="0.0"/>
                    <measurement group_id="O2" value="-0.01" lower_limit="-0.1" upper_limit="0.0"/>
                    <measurement group_id="O3" value="0.00" lower_limit="0.0" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Pain-free State (Day 3) in Grip Force in Pain State (Day 2)</title>
        <description>This task was a measure of grip strength. The participant held the dynamometer in their dominant hand and the arm was swung from above the head to by the side of the body. If the dominant arm or hand was painful then the non-dominant hand was used. The participant was instructed to assert maximum effort during the squeezing motion and maintain it for about 4 seconds using a metronome. Participant conducted the movement 4-times (1 practice effort and 3 test efforts) and there was a 1-minute recovery period between each effort.</description>
        <time_frame>At Day 2 (pre and post-treatment) and Day 3 of the study</time_frame>
        <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol and Caffeine</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pain-free State (Day 3) in Grip Force in Pain State (Day 2)</title>
          <description>This task was a measure of grip strength. The participant held the dynamometer in their dominant hand and the arm was swung from above the head to by the side of the body. If the dominant arm or hand was painful then the non-dominant hand was used. The participant was instructed to assert maximum effort during the squeezing motion and maintain it for about 4 seconds using a metronome. Participant conducted the movement 4-times (1 practice effort and 3 test efforts) and there was a 1-minute recovery period between each effort.</description>
          <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
          <units>Kilogram (Kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from pain-free state at Day 2 pre-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.98" spread="5.505"/>
                    <measurement group_id="O2" value="-3.87" spread="3.792"/>
                    <measurement group_id="O3" value="-1.70" spread="3.533"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from pain-free state at Day2 post-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.68" spread="2.384"/>
                    <measurement group_id="O2" value="-2.80" spread="3.059"/>
                    <measurement group_id="O3" value="-0.46" spread="1.365"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Pain-free State (Day 3) in Time to Standing in Pain State (Day 2)</title>
        <description>Time to standing provides a simple assessment of physical mobility. From a seated position with arms crossed so that the right hand is placed on the left shoulder and the left hand on the right shoulder, participants stood to a fully erect stature in as short a time as possible. Time to standing recorded which was measured using a stopwatch. Participants conducted the same movement 3-times continuously as a practice effort and 5-times continuously as a test effort at each visit. There was a 1-minute rest between the practice and test effort.</description>
        <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
        <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol and Caffeine</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pain-free State (Day 3) in Time to Standing in Pain State (Day 2)</title>
          <description>Time to standing provides a simple assessment of physical mobility. From a seated position with arms crossed so that the right hand is placed on the left shoulder and the left hand on the right shoulder, participants stood to a fully erect stature in as short a time as possible. Time to standing recorded which was measured using a stopwatch. Participants conducted the same movement 3-times continuously as a practice effort and 5-times continuously as a test effort at each visit. There was a 1-minute rest between the practice and test effort.</description>
          <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
          <units>Seconds</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from pain-free state at Day 2 pre-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" lower_limit="-0.4" upper_limit="0.2"/>
                    <measurement group_id="O2" value="0.13" lower_limit="-0.2" upper_limit="0.3"/>
                    <measurement group_id="O3" value="0.09" lower_limit="0.0" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from pain-free state at Day2 post-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" lower_limit="-0.2" upper_limit="0.5"/>
                    <measurement group_id="O2" value="-0.08" lower_limit="-0.3" upper_limit="0.4"/>
                    <measurement group_id="O3" value="0.04" lower_limit="-0.2" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Pain-free State (Day 3) in Ground Reaction Force (GRF) in Pain State (Day 2)</title>
        <description>From a seated position with arms crossed so that the right hand is placed on the left shoulder and the left hand on the right shoulder, participants stood to a fully erect stature in as short a time as possible. Participants conducted the same movement 3-times continuously as a practice effort and 5-times continuously as a test effort at each visit. There was a 1-minute rest between the practice and test effort. GRF was measured during the movement analyzed using a force plate interfaced with a computer.</description>
        <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
        <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol and Caffeine</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pain-free State (Day 3) in Ground Reaction Force (GRF) in Pain State (Day 2)</title>
          <description>From a seated position with arms crossed so that the right hand is placed on the left shoulder and the left hand on the right shoulder, participants stood to a fully erect stature in as short a time as possible. Participants conducted the same movement 3-times continuously as a practice effort and 5-times continuously as a test effort at each visit. There was a 1-minute rest between the practice and test effort. GRF was measured during the movement analyzed using a force plate interfaced with a computer.</description>
          <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
          <units>Newtons</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from pain-free state at Day 2 pre-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.35" spread="11.781"/>
                    <measurement group_id="O2" value="-19.80" spread="43.788"/>
                    <measurement group_id="O3" value="3.75" spread="11.214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from pain-free state at Day2 post-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.21" spread="8.295"/>
                    <measurement group_id="O2" value="-13.85" spread="47.387"/>
                    <measurement group_id="O3" value="3.08" spread="12.064"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Pain-free State (Day 3) in Contact Phase in Pain State (Day 2)</title>
        <description>Participants performed a walking assessment in comfortable walking shoes to measure gait parameter contact phase. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.</description>
        <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
        <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol and Caffeine</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pain-free State (Day 3) in Contact Phase in Pain State (Day 2)</title>
          <description>Participants performed a walking assessment in comfortable walking shoes to measure gait parameter contact phase. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.</description>
          <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
          <units>Seconds</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from pain-free state at Day 2 pre-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" lower_limit="0.0" upper_limit="0.1"/>
                    <measurement group_id="O2" value="0.03" lower_limit="0.0" upper_limit="0.1"/>
                    <measurement group_id="O3" value="0.00" lower_limit="0.0" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from pain-free state at Day2 post-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" lower_limit="-0.0" upper_limit="0.1"/>
                    <measurement group_id="O2" value="0.02" lower_limit="-0.0" upper_limit="0.1"/>
                    <measurement group_id="O3" value="0.01" lower_limit="-0.02" upper_limit="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Pain-free State (Day 3) in Stride Length in Pain State (Day 2)</title>
        <description>Participants performed a walking assessment in comfortable walking shoes to measure gait parameter stride length. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.</description>
        <time_frame>At Day 2 (pre and post treatment) and Day 3 of the study</time_frame>
        <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol and Caffeine</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pain-free State (Day 3) in Stride Length in Pain State (Day 2)</title>
          <description>Participants performed a walking assessment in comfortable walking shoes to measure gait parameter stride length. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.</description>
          <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
          <units>Centimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from pain-free state at Day 2 pre-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.098"/>
                    <measurement group_id="O2" value="-0.08" spread="0.123"/>
                    <measurement group_id="O3" value="-0.02" spread="0.038"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from pain-free state at Day2 post-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.084"/>
                    <measurement group_id="O2" value="-0.06" spread="0.116"/>
                    <measurement group_id="O3" value="-0.04" spread="0.037"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Pain-free State (Day 3) in Walking Speed in Pain State (Day 2)</title>
        <description>Participants performed a walking assessment in comfortable walking shoes to measure gait parameter walking speed over 5-10m for each foot. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.</description>
        <time_frame>At Day 2 (pre and post-treatment) and Day 3</time_frame>
        <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol and Caffeine</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.</description>
          </group>
          <group group_id="O2">
            <title>Paracetamol</title>
            <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 milliliters (mL) of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 milliliters (mL) of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pain-free State (Day 3) in Walking Speed in Pain State (Day 2)</title>
          <description>Participants performed a walking assessment in comfortable walking shoes to measure gait parameter walking speed over 5-10m for each foot. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.</description>
          <population>Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.</population>
          <units>meters/second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from pain-free state at Day 2 pre-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="0.112"/>
                    <measurement group_id="O2" value="-0.10" spread="0.180"/>
                    <measurement group_id="O3" value="-0.02" spread="0.052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from pain-free state at Day2 post-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.105"/>
                    <measurement group_id="O2" value="-0.07" spread="0.157"/>
                    <measurement group_id="O3" value="-0.03" spread="0.043"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 61 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Paracetamol and Caffeine</title>
          <description>All the participants in this arm received test product (containing 500 mg of paracetamol and 65 mg of caffeine). All the participants took 2 tablets at once orally with 200 mL of water.</description>
        </group>
        <group group_id="E2">
          <title>Paracetamol</title>
          <description>All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>All the participants in this arm received reference product (placebo to match Paracetamol 665mg sustained release tablets). All the participants took 2 tablets at once orally with 200 mL of water.</description>
        </group>
      </group_list>
      <serious_events>
        <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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <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="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
              </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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pharyngeal erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated early due to breaches of GCP guidelines observed during a GSKCH internal audit. The minimum requirement of 8 subjects per strata was not met because of early termination so some exploratory analyses were not conducted.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.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/NCT02974114
org study id: 204503
nct id: NCT02974114
lead sponsor: 
This parallel, assessor blind, placebo-controlled, stratified, randomized study will
      investigate the effects of everyday pain on cognition and mobility in otherwise healthy
      individuals.
This study consisted of 3 visits. Visit 1 (Day1, Screening), minimum (min) of 7 days and
      maximum (max) of 28 days gap followed by Visit 2 (Day 2, pain-state assessment), a recovery
      period of min of 2 days and max of 30 days followed by Visit 3 (Day 3, pain-free assessment).
      Participants received treatment once only on Visit 2.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change From Pain Free State (Day 3) in Error Adjusted Simple Reaction Time (SRT) in the Pain State (Day 2)
time frame: At Day 2 (pre and post-treatment) and Day 3 of the study
description: Error adjusted SRT was one of the main outcomes of the Axon Sports Priming Application. The Axon Sports Priming Application is a computerized test performed on a tablet device that measures cognitive performance, namely psychomotor speed. Axon sports test assessment included 1. Pain-state assessment performed at Visit 2 (Day 2 pre-treatment assessment and post-treatment assessment 1hour [hr] ± 15 minutes [mins] post-dosing) and 2. Pain-free assessment performed at Visit 3 (Day 3).
measure: Change From Pain-free State (Day 3) in Reaction Time in the Pain State (Day 2)
time frame: At Day 2 (pre and post-treatment) and Day 3 of the study
description: The reaction time of five-choice reaction time task (provided by Cambridge Cognition) was measured. In five-choice reaction time task, all the participants hold down a button at the bottom of the screen till a yellow spot appears in one of the five circles at the top of the screen. Participants then released the button and touch inside of the circle where the yellow spot appeared as quickly as they can. The median duration, between the onset of the stimulus and the release of the button, was recorded as reaction time. Calculated for correct, assessed trials where the stimulus appeared in any one of five locations.
measure: Change From Pain-free State (Day 3) in Number of One Touch Stockings (OTS) of Cambridge Assessment Problems (on Which the First Box Choice Made Was Correct) in the Pain State (Day 2)
time frame: At Day 2 (pre and post treatment) and Day 3 of the study
description: OTS was a measure of executive function and takes approximately 10 minutes to complete. The participant was shown two displays containing three coloured balls. The displays were presented in such a way that they can easily be perceived as stacks of coloured balls held in stockings or socks suspended from a beam. There was a row of numbered boxes along the bottom of the screen. The test administrator first demonstrated to the participant how to use the balls in the lower display to copy the pattern in the upper display, and completed one demonstration problem, where the solution requires one move. The participant then completed three further problems, one each of two moves, three moves, and four moves. Next, the participant was shown further problems, and participants worked out in their head how many moves the solutions to these problems required, and then touch the appropriate box at the bottom of the screen to indicate their response.
measure: Change From Pain-free State (Day 3) in Attention Switching Task (AST) Congruency Cost in the Pain State (Day 2)
time frame: At Day 2 (pre and post treatment) and Day 3 of the study
description: AST was a measure of executive attention. The test displayed an arrow which can appear on either side of the screen and can point in either direction. Each trial displayed a cue at the top of the screen that indicates whether to press the right or left button. Some trials displayed congruent stimuli (e.g. arrow on the right side of the screen pointing to the right) whereas other trials display incongruent stimuli which require a higher cognitive demand (e.g. arrow on the right side of the screen pointing to the left). The AST congruency cost was the difference between the median latencies of response (from stimulus appearance to button press) on the trials that were congruent versus the trials that were incongruent. It was calculated by subtracting the median of congruent from incongruent latency. A positive score indicated response was faster on congruent trials and a negative score indicated response was faster on incongruent trials.
measure: Change From Pain-free State (Day 3) in Spatial Working Memory (SWM) Between Errors in the Pain State (Day 2)
time frame: At Day 2 (pre and post treatment) and Day 3 of the study
description: SWM task was a measure of working memory. The task involved number of coloured squares (boxes) being shown on the screen. The aim of this test was to find one blue token in the boxes shown to the participants by process of elimination and used these to fill up an empty column on the right-hand side of the screen. The number of boxes gradually increased up to a maximum of eight boxes to search and the colour and position of the boxes changed from trial to trial. SWM between errors was defined as times the participant revisited a box in which a token has previously been found. This was calculated for trials of four, six and eight tokens.
measure: Change From Pain-free State (Day 3) in Rapid Visual Information Processing A Prime (RVPA) in the Pain State (Day 2)
time frame: At Day 2 (pre and post treatment) and Day 3 of the study
description: RVP task was measures of attention. A white box appeared in the centre of the computer screen, inside which digits, from 2 to 9, appeared in a pseudo-random order, at the rate of 100 digits per minute. Participants were requested to detect target sequences of digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the press pad. The RVPA (A prime) was the signal detection measure of sensitivity to the target, regardless of response tendency (the expected range will be 0.00 to 1.00; bad to good). RVP metric was a measure of how good the subject was at detecting target sequences.
measure: Change From Pain-free State (Day 3) in Grip Force in Pain State (Day 2)
time frame: At Day 2 (pre and post-treatment) and Day 3 of the study
description: This task was a measure of grip strength. The participant held the dynamometer in their dominant hand and the arm was swung from above the head to by the side of the body. If the dominant arm or hand was painful then the non-dominant hand was used. The participant was instructed to assert maximum effort during the squeezing motion and maintain it for about 4 seconds using a metronome. Participant conducted the movement 4-times (1 practice effort and 3 test efforts) and there was a 1-minute recovery period between each effort.
measure: Change From Pain-free State (Day 3) in Time to Standing in Pain State (Day 2)
time frame: At Day 2 (pre and post treatment) and Day 3 of the study
description: Time to standing provides a simple assessment of physical mobility. From a seated position with arms crossed so that the right hand is placed on the left shoulder and the left hand on the right shoulder, participants stood to a fully erect stature in as short a time as possible. Time to standing recorded which was measured using a stopwatch. Participants conducted the same movement 3-times continuously as a practice effort and 5-times continuously as a test effort at each visit. There was a 1-minute rest between the practice and test effort.
measure: Change From Pain-free State (Day 3) in Ground Reaction Force (GRF) in Pain State (Day 2)
time frame: At Day 2 (pre and post treatment) and Day 3 of the study
description: From a seated position with arms crossed so that the right hand is placed on the left shoulder and the left hand on the right shoulder, participants stood to a fully erect stature in as short a time as possible. Participants conducted the same movement 3-times continuously as a practice effort and 5-times continuously as a test effort at each visit. There was a 1-minute rest between the practice and test effort. GRF was measured during the movement analyzed using a force plate interfaced with a computer.
measure: Change From Pain-free State (Day 3) in Contact Phase in Pain State (Day 2)
time frame: At Day 2 (pre and post treatment) and Day 3 of the study
description: Participants performed a walking assessment in comfortable walking shoes to measure gait parameter contact phase. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.
measure: Change From Pain-free State (Day 3) in Stride Length in Pain State (Day 2)
time frame: At Day 2 (pre and post treatment) and Day 3 of the study
description: Participants performed a walking assessment in comfortable walking shoes to measure gait parameter stride length. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.
measure: Change From Pain-free State (Day 3) in Walking Speed in Pain State (Day 2)
time frame: At Day 2 (pre and post-treatment) and Day 3
description: Participants performed a walking assessment in comfortable walking shoes to measure gait parameter walking speed over 5-10m for each foot. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.
arm group label: Paracetamol and caffeine
arm group type: Experimental
description: Participants will be administered test product (containing 500 mg paracetamol and 65 mg caffeine). Two tablets will be taken orally once with 200 mL (milliliters) of water.
arm group label: Paracetamol
arm group type: Experimental
description: Participants will be administered test product (containing 500 mg paracetamol). Two tablets will be taken orally once with 200 mL of water.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will be administered reference product (placebo to match Paracetamol 665mg sustained release tablets). Two tablets will be taken orally once with 200 mL of water.
intervention type: Drug
intervention name: Paracetamol and caffeine
description: Test product containing 500 mg paracetamol and 65 mg caffeine
arm group label: Paracetamol and caffeine
intervention type: Drug
intervention name: Paracetamol
description: Test product containing 500 mg paracetamol
arm group label: Paracetamol
intervention type: Other
intervention name: Placebo
description: Placebo to match paracetamol 665mg sustained release tablets
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Acetaminophen
mesh term: Caffeine
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated early due to breaches of GCP guidelines observed during a GSKCH internal audit. The minimum requirement of 8 subjects per strata was not met because of early termination so some exploratory analyses were not conducted.
point of contact: 