<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/NCT02229461</url>
  </required_header>
  <id_info>
    <org_study_id>15525</org_study_id>
    <nct_id>NCT02229461</nct_id>
  </id_info>
  <brief_title>Naproxen Sodium/ASA Platelet Study</brief_title>
  <acronym>Kontakt</acronym>
  <official_title>A Randomized, Open Label, Parallel Group Study to Investigate the Effects on Serum Thromboxane by the Addition of Naproxen Sodium to Aspirin Therapy Versus Aspirin Therapy Alone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory&#xD;
      effect of a low dose Immediate Release Aspirin (IR ASA) regimen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration</measure>
    <time_frame>At hour 24 on Day 16 post treatment</time_frame>
    <description>Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration</measure>
    <time_frame>At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16)</time_frame>
    <description>Inhibition of serum TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration</measure>
    <time_frame>At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19</time_frame>
    <description>Inhibition of AA-induced platelet aggregation at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. The platelet aggregation change-from-baseline scores range broadly in large part due to inclusion of participants with low baseline platelet aggregation scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration</measure>
    <time_frame>At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19</time_frame>
    <description>Inhibition of plasma TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">117</enrollment>
  <condition>Hematology</condition>
  <arm_group>
    <arm_group_label>IR ASA co-administered with naproxen sodium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IR ASA 30 min after naproxen sodium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IR ASA 8 hours after naproxen sodium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IR ASA only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IR ASA 30 min before naproxen sodium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IR ASA 30 min after first dose of naproxen sodium bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naproxen Sodium (Aleve, BAY117031)</intervention_name>
    <description>Naproxen sodium 220 mg qd or bid</description>
    <arm_group_label>IR ASA 30 min after first dose of naproxen sodium bid</arm_group_label>
    <arm_group_label>IR ASA 30 min after naproxen sodium</arm_group_label>
    <arm_group_label>IR ASA 30 min before naproxen sodium</arm_group_label>
    <arm_group_label>IR ASA 8 hours after naproxen sodium</arm_group_label>
    <arm_group_label>IR ASA co-administered with naproxen sodium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetylsalicylic Acid (Aspirin, BAYE4465)</intervention_name>
    <description>ASA 81 mg qd</description>
    <arm_group_label>IR ASA 30 min after first dose of naproxen sodium bid</arm_group_label>
    <arm_group_label>IR ASA 30 min after naproxen sodium</arm_group_label>
    <arm_group_label>IR ASA 30 min before naproxen sodium</arm_group_label>
    <arm_group_label>IR ASA 8 hours after naproxen sodium</arm_group_label>
    <arm_group_label>IR ASA co-administered with naproxen sodium</arm_group_label>
    <arm_group_label>IR ASA only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, ambulatory, male and female volunteers between 18 - 70 years of age with a&#xD;
             Body Mass Index (BMI) of approximately 18 to 30 kg/m2, and a total body weight &gt; 50 kg&#xD;
             (110 lbs)&#xD;
&#xD;
          -  Female subjects of childbearing potential must be using a medically acceptable form of&#xD;
             birth control for at least 1 month prior to screening (3 months on oral&#xD;
             contraceptives), e.g., oral or patch contraceptives, intrauterine device,&#xD;
             Depo-Provera®, or a double barrier and have a negative pregnancy test at Screening and&#xD;
             immediately prior to investigational product administration on Day 1 and Day 6. Female&#xD;
             subjects of non-childbearing potential must be amenorrheic for at least 2 years or had&#xD;
             a hysterectomy and/or bilateral oophorectomy&#xD;
&#xD;
          -  Results of screening and clinical laboratory tests are within normal range or&#xD;
             considered not clinically significant by the Principal Investigator and the Sponsor&#xD;
&#xD;
          -  Be willing and able to participate in all scheduled visits, treatment plan, laboratory&#xD;
             tests and other trial procedures according to the protocol&#xD;
&#xD;
          -  Provide a personally signed and dated informed consent indicating that the subject has&#xD;
             been informed of all pertinent aspects of the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypersensitivity or asthma type symptoms with use of aspirin, naproxen&#xD;
             sodium and similar pharmacological agents or components of the products&#xD;
&#xD;
          -  Females who are pregnant or lactating&#xD;
&#xD;
          -  Any disorder of the Aspirin Triad Syndrome (i.e., asthma, rhinitis or nasal polyps),&#xD;
             or have chronic urticaria&#xD;
&#xD;
          -  Eighteen to twenty years old with a viral infection, with or without fever within one&#xD;
             month prior to start of Run-in Period&#xD;
&#xD;
          -  History of gastrointestinal bleeding or perforation, related to previous NSAID&#xD;
             therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct&#xD;
             episodes of proven ulceration or bleeding)&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,&#xD;
             infectious diseases or malignancies&#xD;
&#xD;
          -  Any abnormal laboratory value or physical finding that according to the Investigator&#xD;
             that may interfere with the interpretation of the study results or be indicative of an&#xD;
             underlying disease state&#xD;
&#xD;
          -  Have taken any medications including NSAIDs (except acceptable forms of birth control)&#xD;
             within 7 days prior to the start of the Run-in Period or throughout the study, unless&#xD;
             in the opinion of the Investigator and the Sponsor, the medication will not interfere&#xD;
             with the study procedures, data integrity, data interpretation or compromise the&#xD;
             safety of the subject&#xD;
&#xD;
          -  Have taken antiplatelet or anticoagulant drugs within 30 days prior to start of the&#xD;
             Run-in Period or during their participation in the study&#xD;
&#xD;
          -  Have donated blood or blood components within 30 days prior to study entry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <results_first_submitted>May 4, 2016</results_first_submitted>
  <results_first_submitted_qc>May 4, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 10, 2016</results_first_posted>
  <last_update_submitted>June 16, 2016</last_update_submitted>
  <last_update_submitted_qc>June 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2016</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>Aspirin</mesh_term>
    <mesh_term>Naproxen</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at a single site in United States between 16-Feb-2015 (first patient first visit) and 08-May-2015 (last patient last visit).</recruitment_details>
      <pre_assignment_details>Of 117 screened participants in Run-In period, 15 were not randomized into Treatment Period. 2 participants were not randomized because of non-compliance; 3 because of investigator's decision; the other 10 because of other reasons (e.g arachidonic acid-induced platelet aggregation≥20% or pre-randomization elimination of back-up participants).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1-IR ASA Co-administered With Naproxen Sodium</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="P2">
          <title>Group 2-IR ASA 30 Min After Naproxen Sodium</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="P3">
          <title>Group 3-IR ASA 8 Hours After Naproxen Sodium</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="P4">
          <title>Group 4-IR ASA Only</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="P5">
          <title>Group 5-IR ASA 30 Min Before Naproxen Sodium</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="P6">
          <title>Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17">Randomized and received treatment</participants>
                <participants group_id="P2" count="17">Randomized and received treatment</participants>
                <participants group_id="P3" count="17">Randomized and received treatment</participants>
                <participants group_id="P4" count="17">Randomized and received treatment</participants>
                <participants group_id="P5" count="17">Randomized and received treatment</participants>
                <participants group_id="P6" count="17">Randomized and received treatment</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="17"/>
                <participants group_id="P5" count="17"/>
                <participants group_id="P6" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1-IR ASA Co-administered With Naproxen Sodium</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="B2">
          <title>Group 2-IR ASA 30 Min After Naproxen Sodium</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="B3">
          <title>Group 3-IR ASA 8 Hours After Naproxen Sodium</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="B4">
          <title>Group 4-IR ASA Only</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="B5">
          <title>Group 5-IR ASA 30 Min Before Naproxen Sodium</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="B6">
          <title>Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="B7">
          <title>Non-Randomized</title>
          <description>Fifteen participants were not randomized into Treatment Period.</description>
        </group>
        <group group_id="B8">
          <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="17"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="17"/>
            <count group_id="B4" value="17"/>
            <count group_id="B5" value="17"/>
            <count group_id="B6" value="17"/>
            <count group_id="B7" value="15"/>
            <count group_id="B8" value="117"/>
          </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="41.3" spread="8.46"/>
                    <measurement group_id="B2" value="31.2" spread="7.19"/>
                    <measurement group_id="B3" value="37.5" spread="13.41"/>
                    <measurement group_id="B4" value="34.2" spread="8.76"/>
                    <measurement group_id="B5" value="38.8" spread="12.09"/>
                    <measurement group_id="B6" value="38.9" spread="10.62"/>
                    <measurement group_id="B7" value="38.2" spread="13.74"/>
                    <measurement group_id="B8" value="37.1" spread="11.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="10"/>
                    <measurement group_id="B7" value="11"/>
                    <measurement group_id="B8" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration</title>
        <description>Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.</description>
        <time_frame>At hour 24 on Day 16 post treatment</time_frame>
        <population>Percentages are based on the number of participants in the Evaluable Population in each treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1-IR ASA Co-administered With Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O2">
            <title>Group 2-IR ASA 30 Min After Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O3">
            <title>Group 3-IR ASA 8 Hours After Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O4">
            <title>Group 4-IR ASA Only</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O5">
            <title>Group 5-IR ASA 30 Min Before Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O6">
            <title>Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
        </group_list>
        <measure>
          <title>Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration</title>
          <description>Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.</description>
          <population>Percentages are based on the number of participants in the Evaluable Population in each treatment group.</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.09" lower_limit="91.50" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="87.71" lower_limit="85.51" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="92.87" lower_limit="91.24" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="98.72" lower_limit="98.49" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="95.35" lower_limit="94.14" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="95.65" lower_limit="94.74" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration</title>
        <description>Inhibition of serum TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.</description>
        <time_frame>At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16)</time_frame>
        <population>Percentages are based on the number of participants in the Evaluable Population in each treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1-IR ASA Co-administered With Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O2">
            <title>Group 2-IR ASA 30 Min After Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O3">
            <title>Group 3-IR ASA 8 Hours After Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O4">
            <title>Group 4-IR ASA Only</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O5">
            <title>Group 5-IR ASA 30 Min Before Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O6">
            <title>Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
        </group_list>
        <measure>
          <title>Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration</title>
          <description>Inhibition of serum TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.</description>
          <population>Percentages are based on the number of participants in the Evaluable Population in each treatment group.</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7 at 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.86" lower_limit="99.82" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="99.83" lower_limit="99.81" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="99.69" lower_limit="99.63" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.67" lower_limit="99.60" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="99.91" lower_limit="99.87" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="99.84" lower_limit="99.81" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 3 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.84" lower_limit="99.79" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="99.79" lower_limit="99.76" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="99.54" lower_limit="99.46" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.66" lower_limit="99.58" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="99.86" lower_limit="99.81" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="99.80" lower_limit="99.77" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 6 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.69" lower_limit="99.58" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="99.67" lower_limit="99.60" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="99.44" lower_limit="99.34" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.48" lower_limit="99.36" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="99.75" lower_limit="99.63" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="99.70" lower_limit="99.65" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 12 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.59" lower_limit="99.46" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="99.48" lower_limit="99.42" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="99.12" lower_limit="98.98" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.31" lower_limit="99.17" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="99.68" lower_limit="99.57" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="99.63" lower_limit="99.56" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 18 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.18" lower_limit="99.01" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="99.18" lower_limit="99.04" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="99.76" lower_limit="99.71" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="98.86" lower_limit="98.68" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="99.39" lower_limit="99.19" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="99.70" lower_limit="99.64" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 24 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.01" lower_limit="98.76" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="99.55" lower_limit="99.43" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="97.78" lower_limit="96.51" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="98.71" lower_limit="98.46" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="99.23" lower_limit="99.00" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="99.80" lower_limit="99.75" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.06" lower_limit="98.79" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="98.38" lower_limit="98.10" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="98.32" lower_limit="98.09" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.71" lower_limit="99.64" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="99.28" lower_limit="99.08" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="98.81" lower_limit="98.59" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 3 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.80" lower_limit="98.49" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="97.67" lower_limit="97.41" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="98.02" lower_limit="97.68" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.68" lower_limit="99.60" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="99.19" lower_limit="99.00" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="98.53" lower_limit="98.23" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 6 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.69" lower_limit="97.21" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="96.26" lower_limit="95.70" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="97.40" lower_limit="97.03" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.55" lower_limit="99.45" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="98.43" lower_limit="98.05" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="97.51" lower_limit="97.10" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 12 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.59" lower_limit="95.67" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="92.71" lower_limit="91.13" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="96.31" lower_limit="95.68" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.42" lower_limit="99.29" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="97.84" lower_limit="97.10" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="95.38" lower_limit="94.13" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 18 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.19" lower_limit="93.04" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="92.23" lower_limit="90.24" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="95.68" lower_limit="94.62" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.01" lower_limit="98.85" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="96.45" lower_limit="95.43" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="97.73" lower_limit="97.28" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.71" lower_limit="94.31" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="94.63" lower_limit="93.66" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="95.56" lower_limit="94.69" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.70" lower_limit="99.64" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="97.42" lower_limit="96.88" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="96.95" lower_limit="96.30" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 3 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.49" lower_limit="94.38" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="92.79" lower_limit="91.36" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="96.43" lower_limit="95.89" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.68" lower_limit="99.60" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="96.96" lower_limit="96.33" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="95.92" lower_limit="95.03" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 6 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.55" lower_limit="91.86" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="90.91" lower_limit="89.21" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="95.64" lower_limit="94.92" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.52" lower_limit="99.41" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="95.31" lower_limit="94.32" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="93.91" lower_limit="92.61" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 12 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.54" lower_limit="91.08" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="91.15" lower_limit="89.80" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="94.13" lower_limit="93.08" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.30" lower_limit="99.13" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="94.74" lower_limit="93.62" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="92.60" lower_limit="90.92" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 18 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.44" lower_limit="87.48" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="87.19" lower_limit="85.43" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="94.23" lower_limit="93.42" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="98.95" lower_limit="98.76" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="93.42" lower_limit="92.27" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="88.14" lower_limit="85.42" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 24 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.05" lower_limit="86.86" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="83.67" lower_limit="81.77" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="90.39" lower_limit="88.57" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="98.70" lower_limit="98.48" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="91.40" lower_limit="89.21" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="84.27" lower_limit="80.66" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.35" lower_limit="97.86" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="97.89" lower_limit="97.45" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="98.89" lower_limit="98.64" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.69" lower_limit="99.62" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="98.16" lower_limit="97.74" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="94.06" lower_limit="92.59" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 3 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.52" lower_limit="98.02" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="97.90" lower_limit="97.46" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="99.05" lower_limit="98.93" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.64" lower_limit="99.55" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="98.27" lower_limit="97.92" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="94.44" lower_limit="92.92" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 6 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.26" lower_limit="97.78" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="97.43" lower_limit="96.73" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="98.98" lower_limit="98.81" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.50" lower_limit="99.39" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="97.84" lower_limit="97.34" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="93.25" lower_limit="91.11" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 12 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.67" lower_limit="96.95" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="96.90" lower_limit="96.06" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="98.77" lower_limit="98.57" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="99.26" lower_limit="99.09" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="97.33" lower_limit="96.70" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="92.00" lower_limit="89.44" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 18 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.21" lower_limit="96.40" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="96.29" lower_limit="95.40" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="98.52" lower_limit="98.27" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="98.88" lower_limit="98.67" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="96.62" lower_limit="95.86" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="90.94" lower_limit="88.41" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 24 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.04" lower_limit="96.13" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="96.16" lower_limit="95.25" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="97.98" lower_limit="97.72" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="98.49" lower_limit="98.19" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="96.01" lower_limit="94.86" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="90.67" lower_limit="88.25" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration</title>
        <description>Inhibition of AA-induced platelet aggregation at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. The platelet aggregation change-from-baseline scores range broadly in large part due to inclusion of participants with low baseline platelet aggregation scores.</description>
        <time_frame>At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19</time_frame>
        <population>Percentages are based on the number of participants in the Evaluable Population in each treatment group. Evaluable participants number in Group 4 at time point Day 7/1 Hour was 12; 11 in group 6, 7 in Group 5, 12 in Group 6 at Day 16/1 Hour.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1-IR ASA Co-administered With Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O2">
            <title>Group 2-IR ASA 30 Min After Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O3">
            <title>Group 3-IR ASA 8 Hours After Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O4">
            <title>Group 4-IR ASA Only</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O5">
            <title>Group 5-IR ASA 30 Min Before Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O6">
            <title>Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
        </group_list>
        <measure>
          <title>Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration</title>
          <description>Inhibition of AA-induced platelet aggregation at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. The platelet aggregation change-from-baseline scores range broadly in large part due to inclusion of participants with low baseline platelet aggregation scores.</description>
          <population>Percentages are based on the number of participants in the Evaluable Population in each treatment group. Evaluable participants number in Group 4 at time point Day 7/1 Hour was 12; 11 in group 6, 7 in Group 5, 12 in Group 6 at Day 16/1 Hour.</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7 at 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.60" spread="58.893" lower_limit="29.49" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="12.78" spread="139.818" lower_limit="-53.40" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="5.55" spread="306.389" lower_limit="-133.79" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="87.73" spread="8.777" lower_limit="83.18" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="64.14" spread="40.389" lower_limit="40.73" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="30.45" spread="182.916" lower_limit="-56.12" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 3 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-121.76" spread="630.765" lower_limit="-433.56" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="12.86" spread="144.823" lower_limit="-55.68" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="10.80" spread="280.405" lower_limit="-116.72" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="79.16" spread="29.318" lower_limit="64.67" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="75.89" spread="24.067" lower_limit="61.94" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="18.99" spread="222.208" lower_limit="-86.18" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 6 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.74" spread="63.400" lower_limit="30.40" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="1.70" spread="168.415" lower_limit="-78.01" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="-3.29" spread="331.881" lower_limit="-154.22" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="78.20" spread="33.051" lower_limit="61.86" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="73.69" spread="31.859" lower_limit="55.22" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="26.91" spread="183.636" lower_limit="-60.00" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 12 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.41" spread="162.350" lower_limit="-43.85" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="28.54" spread="113.063" lower_limit="-24.98" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="-17.95" spread="275.811" lower_limit="-143.38" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="80.81" spread="33.244" lower_limit="64.37" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="76.02" spread="26.733" lower_limit="60.52" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="17.11" spread="249.918" lower_limit="-101.18" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 18 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.36" spread="68.382" lower_limit="28.56" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="25.27" spread="119.755" lower_limit="-31.41" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="11.96" spread="280.718" lower_limit="-115.70" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="78.50" spread="37.671" lower_limit="59.88" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="38.58" spread="138.715" lower_limit="-41.83" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="-151.06" spread="863.434" lower_limit="-559.72" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 24 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.60" spread="26.517" lower_limit="67.50" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="46.31" spread="91.924" lower_limit="2.80" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="41.29" spread="178.089" lower_limit="-39.70" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="89.12" spread="18.535" lower_limit="79.96" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="77.61" spread="29.401" lower_limit="60.57" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="44.02" spread="157.466" lower_limit="-30.51" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.96" spread="39.662" lower_limit="49.36" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="24.15" spread="114.782" lower_limit="-38.58" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="29.25" spread="229.744" lower_limit="-75.23" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="86.12" spread="21.728" lower_limit="75.38" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="62.67" spread="45.474" lower_limit="29.27" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="45.12" spread="141.196" lower_limit="-28.08" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 3 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.25" spread="42.568" lower_limit="54.21" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="51.22" spread="74.825" lower_limit="15.81" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="33.12" spread="203.704" lower_limit="-59.52" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="85.92" spread="21.762" lower_limit="75.16" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="83.51" spread="21.986" lower_limit="70.77" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="37.09" spread="170.694" lower_limit="-43.70" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 6 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.45" spread="42.678" lower_limit="53.35" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="61.20" spread="63.333" lower_limit="31.22" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="62.32" spread="100.840" lower_limit="16.46" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="81.36" spread="37.422" lower_limit="62.86" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="82.55" spread="17.893" lower_limit="72.18" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="81.07" spread="26.570" lower_limit="68.49" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 12 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.88" spread="26.425" lower_limit="66.81" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="70.98" spread="51.499" lower_limit="46.61" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="11.16" spread="254.042" lower_limit="-104.37" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="81.38" spread="31.472" lower_limit="65.82" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="79.51" spread="21.218" lower_limit="67.21" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="53.04" spread="118.315" lower_limit="-2.96" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 18 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.86" spread="36.769" lower_limit="55.68" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="74.07" spread="40.473" lower_limit="54.92" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="35.43" spread="204.054" lower_limit="-57.37" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="85.19" spread="25.762" lower_limit="72.45" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="71.93" spread="52.602" lower_limit="41.44" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="71.64" spread="52.123" lower_limit="46.97" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 24 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.47" spread="37.467" lower_limit="48.95" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="64.26" spread="51.050" lower_limit="40.10" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="15.96" spread="281.846" lower_limit="-112.22" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="85.25" spread="18.848" lower_limit="75.93" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="73.73" spread="32.648" lower_limit="54.81" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="51.40" spread="116.489" lower_limit="-3.73" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.23" spread="30.966" lower_limit="60.92" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="56.77" spread="63.792" lower_limit="26.57" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="-452.48" spread="2088.027" lower_limit="-1402.05" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="83.53" spread="25.476" lower_limit="70.94" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="82.13" spread="19.364" lower_limit="70.90" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="33.64" spread="197.114" lower_limit="-59.65" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 3 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.48" spread="27.969" lower_limit="64.66" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="46.16" spread="79.122" lower_limit="8.71" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="21.74" spread="255.742" lower_limit="-94.56" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="83.48" spread="25.466" lower_limit="70.89" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="75.15" spread="30.948" lower_limit="57.21" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="48.27" spread="117.511" lower_limit="-7.35" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 6 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.46" spread="36.017" lower_limit="58.65" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="69.16" spread="43.503" lower_limit="48.57" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="37.52" spread="204.341" lower_limit="-55.41" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="83.48" spread="25.514" lower_limit="70.87" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="74.61" spread="38.546" lower_limit="52.27" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="52.03" spread="131.415" lower_limit="-10.17" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 12 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.17" spread="20.398" lower_limit="73.08" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="86.40" spread="17.991" lower_limit="77.88" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="-24.72" spread="408.994" lower_limit="-210.72" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="86.00" spread="17.935" lower_limit="77.13" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="82.37" spread="27.172" lower_limit="66.62" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="67.55" spread="79.461" lower_limit="29.95" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 18 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.30" spread="22.570" lower_limit="71.15" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="68.65" spread="45.824" lower_limit="46.96" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="31.96" spread="178.297" lower_limit="-49.12" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="83.71" spread="25.383" lower_limit="71.17" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="71.35" spread="31.709" lower_limit="52.97" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="41.51" spread="144.334" lower_limit="-26.81" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 24 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.66" spread="36.988" lower_limit="60.37" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="70.84" spread="46.622" lower_limit="48.77" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="53.24" spread="103.247" lower_limit="6.29" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="85.43" spread="25.873" lower_limit="72.64" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="82.13" spread="29.286" lower_limit="65.15" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="87.02" spread="23.703" lower_limit="75.80" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.06" spread="64.304" lower_limit="32.28" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="41.10" spread="103.816" lower_limit="-8.04" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="21.46" spread="255.470" lower_limit="-94.72" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="83.97" spread="25.386" lower_limit="71.42" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="81.05" spread="19.743" lower_limit="69.60" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="43.92" spread="157.676" lower_limit="-30.71" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 3 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.18" spread="58.761" lower_limit="40.13" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="48.51" spread="73.341" lower_limit="13.80" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="23.64" spread="228.479" lower_limit="-80.27" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="81.62" spread="33.415" lower_limit="65.10" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="78.01" spread="26.265" lower_limit="62.78" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="14.85" spread="263.930" lower_limit="-110.07" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 6 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.96" spread="72.629" lower_limit="25.06" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="50.21" spread="77.242" lower_limit="13.65" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="51.59" spread="126.753" lower_limit="-6.05" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="82.98" spread="29.512" lower_limit="68.39" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="70.87" spread="35.515" lower_limit="50.28" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="58.64" spread="105.239" lower_limit="8.83" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 12 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" spread="313.927" lower_limit="-154.10" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="33.43" spread="110.105" lower_limit="-18.68" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="36.92" spread="204.360" lower_limit="-56.02" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="84.45" spread="25.743" lower_limit="71.72" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="44.97" spread="112.099" lower_limit="-20.01" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="13.17" spread="215.066" lower_limit="-88.62" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 18 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.69" spread="57.918" lower_limit="41.06" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="74.55" spread="46.130" lower_limit="52.71" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="15.41" spread="281.253" lower_limit="-112.49" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="91.12" spread="4.541" lower_limit="88.88" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="88.43" spread="10.953" lower_limit="82.08" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="84.46" spread="28.685" lower_limit="70.88" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 24 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.86" spread="13.568" lower_limit="83.15" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="80.90" spread="28.329" lower_limit="67.49" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="29.02" spread="230.055" lower_limit="-75.60" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="83.67" spread="34.194" lower_limit="66.77" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="82.63" spread="20.393" lower_limit="70.80" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="71.27" spread="57.042" lower_limit="44.27" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration</title>
        <description>Inhibition of plasma TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.</description>
        <time_frame>At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19</time_frame>
        <population>Percentages are based on the number of participants in the Evaluable Population in each treatment group. Evaluable participants number in Group 1 at time point Day 7/1 Hour, Day 7/3 Hour, Day 7/6 Hour, Day 7/12 Hour was 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1-IR ASA Co-administered With Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O2">
            <title>Group 2-IR ASA 30 Min After Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O3">
            <title>Group 3-IR ASA 8 Hours After Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O4">
            <title>Group 4-IR ASA Only</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O5">
            <title>Group 5-IR ASA 30 Min Before Naproxen Sodium</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
          <group group_id="O6">
            <title>Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid</title>
            <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
          </group>
        </group_list>
        <measure>
          <title>Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration</title>
          <description>Inhibition of plasma TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.</description>
          <population>Percentages are based on the number of participants in the Evaluable Population in each treatment group. Evaluable participants number in Group 1 at time point Day 7/1 Hour, Day 7/3 Hour, Day 7/6 Hour, Day 7/12 Hour was 12.</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7 at 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.84" lower_limit="98.35" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="98.82" lower_limit="98.33" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="97.59" lower_limit="96.62" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="98.34" lower_limit="97.61" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="99.40" lower_limit="99.17" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="98.67" lower_limit="98.14" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 3 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.82" lower_limit="97.00" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="98.25" lower_limit="97.48" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="97.72" lower_limit="97.03" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="97.61" lower_limit="96.55" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="98.95" lower_limit="98.49" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="97.68" lower_limit="96.44" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 6 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.95" lower_limit="96.59" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="98.57" lower_limit="97.83" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="98.37" lower_limit="97.63" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="97.29" lower_limit="96.46" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="99.06" lower_limit="98.42" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="97.93" lower_limit="97.29" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 12 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.75" lower_limit="96.69" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="97.92" lower_limit="96.72" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="96.66" lower_limit="95.59" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="97.49" lower_limit="96.71" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="98.54" lower_limit="97.70" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="98.36" lower_limit="97.52" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 18 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.85" lower_limit="96.65" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="96.09" lower_limit="94.63" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="98.79" lower_limit="98.32" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="96.29" lower_limit="94.83" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="97.97" lower_limit="96.94" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="97.87" lower_limit="96.98" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 at 24 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.62" lower_limit="95.38" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="98.26" lower_limit="97.59" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="98.89" lower_limit="98.42" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="95.04" lower_limit="93.35" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="98.13" lower_limit="97.54" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="98.44" lower_limit="97.81" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.06" lower_limit="97.15" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="95.49" lower_limit="93.79" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="89.55" lower_limit="87.09" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="98.99" lower_limit="98.59" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="96.73" lower_limit="95.54" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="94.95" lower_limit="92.99" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 3 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.03" lower_limit="90.35" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="89.25" lower_limit="85.98" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="92.62" lower_limit="90.24" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="97.37" lower_limit="96.45" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="96.17" lower_limit="95.16" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="90.62" lower_limit="87.59" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 6 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.55" lower_limit="89.83" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="88.62" lower_limit="83.96" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="90.40" lower_limit="88.30" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="98.50" lower_limit="97.89" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="95.56" lower_limit="93.74" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="91.27" lower_limit="87.89" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 12 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.55" lower_limit="86.80" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="85.63" lower_limit="80.50" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="88.76" lower_limit="85.89" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="97.42" lower_limit="96.77" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="92.30" lower_limit="90.55" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="89.45" lower_limit="84.52" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 18 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.61" lower_limit="82.69" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="84.41" lower_limit="80.03" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="82.14" lower_limit="75.75" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="95.69" lower_limit="94.57" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="93.28" lower_limit="91.00" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="91.03" lower_limit="87.81" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 at 24 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.42" lower_limit="80.81" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="72.66" lower_limit="65.53" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="77.71" lower_limit="72.15" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="95.78" lower_limit="94.35" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="88.49" lower_limit="84.08" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="86.87" lower_limit="81.86" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.19" lower_limit="80.48" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="79.99" lower_limit="74.59" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="86.14" lower_limit="83.15" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="98.72" lower_limit="98.30" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="93.75" lower_limit="91.26" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="90.00" lower_limit="84.47" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 3 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.45" lower_limit="79.85" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="90.16" lower_limit="87.39" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="92.60" lower_limit="90.38" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="98.01" lower_limit="97.13" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="88.52" lower_limit="84.47" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="83.94" lower_limit="78.25" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 6 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.90" lower_limit="75.87" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="84.77" lower_limit="80.99" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="83.08" lower_limit="77.53" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="97.34" lower_limit="96.57" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="92.39" lower_limit="89.45" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="85.82" lower_limit="79.55" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 12 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.49" lower_limit="76.38" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="81.22" lower_limit="75.88" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="86.50" lower_limit="82.09" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="97.46" lower_limit="96.40" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="92.42" lower_limit="88.90" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="82.13" lower_limit="76.07" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 18 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.77" lower_limit="81.67" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="78.34" lower_limit="72.79" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="86.53" lower_limit="82.83" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="95.47" lower_limit="93.79" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="85.70" lower_limit="82.50" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="70.90" lower_limit="62.89" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 at 24 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.55" lower_limit="72.74" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="79.06" lower_limit="72.89" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="75.67" lower_limit="70.44" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="97.23" lower_limit="96.19" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="92.07" lower_limit="89.87" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="81.34" lower_limit="76.55" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.68" lower_limit="89.50" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="89.65" lower_limit="86.17" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="95.32" lower_limit="93.74" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="98.05" lower_limit="97.37" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="94.39" lower_limit="91.69" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="79.36" lower_limit="73.75" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 3 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.03" lower_limit="88.18" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="92.04" lower_limit="90.13" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="93.68" lower_limit="91.71" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="97.82" lower_limit="97.16" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="94.53" lower_limit="91.78" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="79.82" lower_limit="74.39" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 6 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.57" lower_limit="87.64" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="91.49" lower_limit="88.95" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="92.35" lower_limit="90.34" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="98.24" lower_limit="97.66" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="93.72" lower_limit="90.55" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="81.14" lower_limit="77.02" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 12 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.59" lower_limit="88.31" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="89.25" lower_limit="86.51" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="95.18" lower_limit="93.46" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="96.91" lower_limit="95.87" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="92.84" lower_limit="90.52" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="80.66" lower_limit="75.32" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 18 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.20" lower_limit="87.58" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="93.50" lower_limit="91.00" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="94.85" lower_limit="92.96" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="96.24" lower_limit="95.27" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="92.74" lower_limit="89.92" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="85.67" lower_limit="81.17" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 at 24 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.76" lower_limit="91.18" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O2" value="90.93" lower_limit="87.80" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O3" value="93.66" lower_limit="91.58" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O4" value="96.63" lower_limit="95.39" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O5" value="96.14" lower_limit="93.74" upper_limit="NA">One-sided 95% CI</measurement>
                    <measurement group_id="O6" value="81.67" lower_limit="74.94" upper_limit="NA">One-sided 95% CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.</time_frame>
      <desc>Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 0-IR ASA 81 mg qd in Run-in Period</title>
          <description>Participants, subsequently randomized to treatment period, were administered the first dose of immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily at the clinical study site and instructed to take the remaining 5 doses in a fasted state with a full glass of water once daily in the morning in an outpatient setting.</description>
        </group>
        <group group_id="E2">
          <title>Group 1-IR ASA Co-administered With Naproxen Sodium</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="E3">
          <title>Group 2-IR ASA 30 Min After Naproxen Sodium</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="E4">
          <title>Group 3-IR ASA 8 Hours After Naproxen Sodium</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="E5">
          <title>Group 4-IR ASA Only</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="E6">
          <title>Group 5-IR ASA 30 Min Before Naproxen Sodium</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
        <group group_id="E7">
          <title>Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid</title>
          <description>Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Non-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="102"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Infrequent bowel movements</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Vessel puncture site bruise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Coagulation time prolonged</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pelvic discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head</name_or_title>
      <organization>BAYER</organization>
      <email>clinical-trials-contact@bayerhealthcare.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/NCT02229461
org study id: 15525
nct id: NCT02229461
lead sponsor: 
has dmc: No
To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory
      effect of a low dose Immediate Release Aspirin (IR ASA) regimen.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration
time frame: At hour 24 on Day 16 post treatment
description: Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.
measure: Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
time frame: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16)
description: Inhibition of serum TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.
measure: Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
time frame: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19
description: Inhibition of AA-induced platelet aggregation at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. The platelet aggregation change-from-baseline scores range broadly in large part due to inclusion of participants with low baseline platelet aggregation scores.
measure: Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
time frame: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19
description: Inhibition of plasma TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.
arm group label: IR ASA co-administered with naproxen sodium
arm group type: Experimental
description: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
arm group label: IR ASA 30 min after naproxen sodium
arm group type: Experimental
description: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
arm group label: IR ASA 8 hours after naproxen sodium
arm group type: Experimental
description: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
arm group label: IR ASA only
arm group type: Active Comparator
description: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
arm group label: IR ASA 30 min before naproxen sodium
arm group type: Experimental
description: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
arm group label: IR ASA 30 min after first dose of naproxen sodium bid
arm group type: Experimental
description: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
intervention type: Drug
intervention name: Naproxen Sodium (Aleve, BAY117031)
description: Naproxen sodium 220 mg qd or bid
arm group label: IR ASA 30 min after first dose of naproxen sodium bid
arm group label: IR ASA 30 min after naproxen sodium
arm group label: IR ASA 30 min before naproxen sodium
arm group label: IR ASA 8 hours after naproxen sodium
arm group label: IR ASA co-administered with naproxen sodium
intervention type: Drug
intervention name: Acetylsalicylic Acid (Aspirin, BAYE4465)
description: ASA 81 mg qd
arm group label: IR ASA 30 min after first dose of naproxen sodium bid
arm group label: IR ASA 30 min after naproxen sodium
arm group label: IR ASA 30 min before naproxen sodium
arm group label: IR ASA 8 hours after naproxen sodium
arm group label: IR ASA co-administered with naproxen sodium
arm group label: IR ASA only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: United States
responsible party type: Sponsor
mesh term: Aspirin
mesh term: Naproxen
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 