<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/NCT01667679</url>
  </required_header>
  <id_info>
    <org_study_id>OPN-SUM-MIG-3302</org_study_id>
    <nct_id>NCT01667679</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura</brief_title>
  <acronym>COMPASS</acronym>
  <official_title>A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Cross-Over Study Evaluating the Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Avanir Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Avanir Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through&#xD;
      the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with migraine&#xD;
      headaches in 30 minutes after use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective for this study is to compare the proportion of attacks in which pain&#xD;
      reduction (defined as a decrease in pain intensity of at least 1 point) is achieved at 30&#xD;
      minutes following 20 mg OPTINOSE SUMATRIPTAN treatment with 100 mg Sumatriptan Tablets&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Sum of Migraine Pain Intensity Differences (SPID)-30</measure>
    <time_frame>Baseline and 30 minutes post-dose (up to 24 weeks)</time_frame>
    <description>SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild, moderate, or severe. The range of possible scores is -60 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of &quot;0&quot; indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an analysis of covariance (ANCOVA) model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The Last Observation Carried Forward (LOCF) imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe</measure>
    <time_frame>Baseline and 30 minutes post-dose (up to 24 weeks)</time_frame>
    <description>SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild and moderate/severe (rated on a 4-point scale: 0=none, 1=mild, 2=moderate, and 3=severe). The range of possible scores for all participants is -60 to +90. For participants with a mild headache at Baseline, the SPID range is -60 to +30. For participants with a moderate/severe headache at Baseline, the SPID range is -30 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of &quot;0&quot; indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The LOCF imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Attacks in Which Pain Reduction Was Achieved</measure>
    <time_frame>10, 15, 30, 45, 60, 90, and 120 minutes</time_frame>
    <description>Percentage of attacks in which pain reduction (defined as a decrease in pain intensity of at least one point on the following scale: 0, none; 1, mild; 2, moderate; 3, severe) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Attacks in Which Pain Freedom Was Achieved</measure>
    <time_frame>Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)</time_frame>
    <description>Percentage of attacks in which pain freedom (defined as pain level reduced to none [Grade 0]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Attacks in Which Pain Relief Was Achieved</measure>
    <time_frame>Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)</time_frame>
    <description>Percentage of attacks treated at a severity of moderate (Grade 2) or severe (Grade 3) in which pain relief (defined as pain level reduced to none [Grade 0] or mild [Grade 1]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to Pain Freedom</measure>
    <time_frame>120 minutes post-dose (up to 24 weeks)</time_frame>
    <description>Pain freedom is defined as a pain level reduced to none (Grade 0).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose</measure>
    <time_frame>Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)</time_frame>
    <description>Participants were required to record their headache severity score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their headaches on the following severity scale: 0, none; 1, mild; 2, moderate; 3, severe. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose</measure>
    <time_frame>Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)</time_frame>
    <description>Participants were required to record their clinical disability score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event</measure>
    <time_frame>Baseline compared to Vist 2, 3 and 4</time_frame>
    <description>An adverse event is defined as any untoward medical occurrence associated with the use of an investigational product in humans, whether or not it is considered related to the investigational product. This includes any occurrence that was new in onset or aggravated in severity or frequency from the Baseline condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>Change from Baseline in hemoglobin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>Change from Baseline in hematocrit (proportion of total blood volume that is composed of red blood cells) was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>Change from Baseline in red blood cell count was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>Change from Baseline in white blood cell (WBC) count, basinophils, monocytes, neutrophils, lymphocytes, eosinophils, and platelets was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>Change from Baseline in urea was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>Change from Baseline in creatinine was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>Change from Baseline in ALP and ALT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>Change from Baseline in AST and GGT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>Change from Baseline in total bilirubin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>Change from Baseline in albumin and total protein was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>Change from Baseline in sodium, potassium, chloride, calcium, and glucose was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>Change from Baseline in urinalysis values was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Data are based on standard reads, with &quot;1+,&quot; &quot;2+,&quot; and &quot;3+&quot; indicating increasing amounts of metabolites in urine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>Change from Baseline in SBP and DBP was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>Change from Baseline in pulse was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). A categorization of &quot;normal&quot; or &quot;abnormal&quot; was made per the investigators' clinical judgment of the ECG, taking the participants' demographic characteristics and other medical conditions into account. CS = clinically significant. CNS = clinically not significant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)</measure>
    <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
    <description>The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). CS = clinically significant. CNS = clinically not significant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With the Indicated Concomitant Medications</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Concomitant medications are defined as non-study medications with a start or stop date between the first dose of study medication and the end of safety follow-up, inclusive. Derm. = dermatologic; incl. - including.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">275</enrollment>
  <condition>Migraine</condition>
  <condition>Headaches</condition>
  <arm_group>
    <arm_group_label>OPTINOSE SUMATRIPTAN and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 mg OPTINOSE SUMATRIPTAN Powder Delivered Intranasally With the Bi-directional Device nasally and Placebo Tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>100mg Sumatriptan and OPTINOSE Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally</intervention_name>
    <arm_group_label>100mg Sumatriptan and OPTINOSE Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet</intervention_name>
    <arm_group_label>OPTINOSE SUMATRIPTAN and Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman, between the ages of 18 to 65 years, inclusive at screening&#xD;
&#xD;
          -  Have a diagnosis of episodic migraine, with or without aura according to&#xD;
             InternationalClassification of Headache Disorders (2nd Edition) (ICHD-2) for at least&#xD;
             1 year prior to screening&#xD;
&#xD;
          -  Experiences between 2 and 8 migraine attacks per month for the past 12 months&#xD;
&#xD;
          -  Women of child bearing potential must be practicing an effective method of birth&#xD;
             control&#xD;
&#xD;
          -  Women of child-bearing potential must have a negative urine pregnancy test at the&#xD;
             screening visit and a negative urine pregnancy test at the randomization visit&#xD;
&#xD;
          -  Demonstrate the ability to use the bi-directional delivery device correctly&#xD;
&#xD;
          -  Able and willing to read and comprehend written instructions and complete the&#xD;
             electronic diary information required by the protocol&#xD;
&#xD;
          -  Must be capable, in the opinion of the Investigator, of providing informed consent to&#xD;
             participate in the study. Subjects (and their legally acceptable representatives, if&#xD;
             applicable) must sign an informed consent document indicating that they understand the&#xD;
             purpose of and procedures required for the study and are willing to participate in the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to distinguish other headaches from migraine&#xD;
&#xD;
          -  Experiences headache of any kind at a frequency greater than or equal to 15 days per&#xD;
             month&#xD;
&#xD;
          -  History of resistance to sumatriptan, or non-response to 2 or more other triptans,&#xD;
             defined as subjects who have not responded to an adequate dose and duration of&#xD;
             treatment&#xD;
&#xD;
          -  Current use of medication for migraine prophylaxis that has not been stable (no dose&#xD;
             adjustment) for 30 days prior to screening&#xD;
&#xD;
          -  Chronic opioid therapy (&gt;3 consecutive days in the 30 days prior to screening)&#xD;
&#xD;
          -  Current treatment with monoamine oxidase A (MAO-A) inhibitors or use within 4 weeks&#xD;
             before randomization&#xD;
&#xD;
          -  Have hemiplegic or basilar migraine&#xD;
&#xD;
          -  History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular&#xD;
             syndromes. Ischemic cardiac syndromes include, but are not limited to, angina pectoris&#xD;
             of any type (e.g., stable angina of effort, vasospastic forms of angina such as the&#xD;
             Prinzmetal variant), all forms of myocardial infarction and silent myocardial&#xD;
             ischemia. Cerebrovascular syndromes include, but are not limited to, strokes of any&#xD;
             type as well as transient ischemic attacks. Peripheral vascular disease includes, but&#xD;
             is not limited to, ischemic bowel disease, Raynaud syndrome&#xD;
&#xD;
          -  Uncontrolled hypertension (screening systolic/diastolic blood pressure &gt;140/95 mmHg)&#xD;
&#xD;
          -  Have severe hepatic impairment&#xD;
&#xD;
          -  Have history of epilepsy or conditions associated with a lowered seizure threshold&#xD;
&#xD;
          -  History (within 2 years) of drug or alcohol abuse as defined by Diagnostic and&#xD;
             Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>San Francisco Clinical Research Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Medical Clinic for Headache</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Neurologists of Southern CT, P.C.</name>
      <address>
        <city>Fairfied</city>
        <state>Connecticut</state>
        <zip>06824</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premiere Research Institute</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedVadis</name>
      <address>
        <city>Watertown</city>
        <state>Massachusetts</state>
        <zip>02472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Head and Pain Institute</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104-5199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinVest</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Health Research</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DENT Neurologic Institute</name>
      <address>
        <city>Amherst</city>
        <state>New York</state>
        <zip>14226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Headache Welness Center</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Winston Salem, LLC</name>
      <address>
        <city>Winston Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jefferson Headache Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Carolina Research Center</name>
      <address>
        <city>Mt. Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <results_first_submitted>October 13, 2016</results_first_submitted>
  <results_first_submitted_qc>January 24, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 14, 2017</results_first_posted>
  <last_update_submitted>March 14, 2017</last_update_submitted>
  <last_update_submitted_qc>March 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Migraine</keyword>
  <keyword>Headaches</keyword>
  <keyword>Sumatriptan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sumatriptan</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 334 participants were assessed for eligibility; of these, 275 participants were randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
          <description>In Treatment Period (TP) 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
        </group>
        <group group_id="P2">
          <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
          <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period 1 (&lt;=12 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="138"/>
                <participants group_id="P2" count="137"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="122"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Failure to Treat Migraine Headache</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Dosed Incorrectly</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Could Not Tolerate Diary</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Moved Out of State</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period 2 (&lt;=12 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="122"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="85"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with Electronic Diary</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failure to Treat Migraine Headache</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Significant Improvement in Migraine</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Partially Dosed</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Brought in before 12 Weeks/5 Migraines</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Refused Last Day of Visit 4 Procedures</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline data are reported for participants in the Safety Analysis Set, defined as all randomized participants who received at least one dose of sumatriptan (20 mg nasal powder or 100 mg tablet).</population>
      <group_list>
        <group group_id="B1">
          <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
          <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1, participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril.</description>
        </group>
        <group group_id="B2">
          <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
          <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1, participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="133"/>
            <count group_id="B2" value="129"/>
            <count group_id="B3" value="262"/>
          </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="39.5" spread="12.55"/>
                    <measurement group_id="B2" value="40.7" spread="11.93"/>
                    <measurement group_id="B3" value="40.1" spread="12.24"/>
                  </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="107"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="222"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="204"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Sum of Migraine Pain Intensity Differences (SPID)-30</title>
        <description>SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild, moderate, or severe. The range of possible scores is -60 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of &quot;0&quot; indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an analysis of covariance (ANCOVA) model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The Last Observation Carried Forward (LOCF) imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.</description>
        <time_frame>Baseline and 30 minutes post-dose (up to 24 weeks)</time_frame>
        <population>Full Analysis Set (FAS): all participants who experienced at least 1 headache attack per treatment period, received at least 1 dose of study medication (sumatriptan nasal powder or tablet) in each treatment period, and had at least 1 post-Baseline assessment for a treated attack in each treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan Nasal Powder</title>
            <description>Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan Tablet</title>
            <description>Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Sum of Migraine Pain Intensity Differences (SPID)-30</title>
          <description>SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild, moderate, or severe. The range of possible scores is -60 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of &quot;0&quot; indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an analysis of covariance (ANCOVA) model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The Last Observation Carried Forward (LOCF) imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.</description>
          <population>Full Analysis Set (FAS): all participants who experienced at least 1 headache attack per treatment period, received at least 1 dose of study medication (sumatriptan nasal powder or tablet) in each treatment period, and had at least 1 post-Baseline assessment for a treated attack in each treatment period.</population>
          <units>scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.80" spread="0.880"/>
                    <measurement group_id="O2" value="7.41" spread="0.880"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.39</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.824</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.76</ci_lower_limit>
            <ci_upper_limit>5.01</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe</title>
        <description>SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild and moderate/severe (rated on a 4-point scale: 0=none, 1=mild, 2=moderate, and 3=severe). The range of possible scores for all participants is -60 to +90. For participants with a mild headache at Baseline, the SPID range is -60 to +30. For participants with a moderate/severe headache at Baseline, the SPID range is -30 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of &quot;0&quot; indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The LOCF imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.</description>
        <time_frame>Baseline and 30 minutes post-dose (up to 24 weeks)</time_frame>
        <population>FAS. Only those participants with the type of attack specified were analyzed (specified by n=X, X in the corresponding category title). A single participant could have had both a mild and a moderate/severe attack.</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan Nasal Powder</title>
            <description>Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan Tablet</title>
            <description>Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe</title>
          <description>SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild and moderate/severe (rated on a 4-point scale: 0=none, 1=mild, 2=moderate, and 3=severe). The range of possible scores for all participants is -60 to +90. For participants with a mild headache at Baseline, the SPID range is -60 to +30. For participants with a moderate/severe headache at Baseline, the SPID range is -30 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of &quot;0&quot; indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The LOCF imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.</description>
          <population>FAS. Only those participants with the type of attack specified were analyzed (specified by n=X, X in the corresponding category title). A single participant could have had both a mild and a moderate/severe attack.</population>
          <units>scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>mild attacks, n=113, 109</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.90" spread="0.921"/>
                    <measurement group_id="O2" value="0.24" spread="0.931"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>moderate/severe attacks, n=158, 168</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.83" spread="1.022"/>
                    <measurement group_id="O2" value="10.07" spread="0.997"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0013</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.66</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.105</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.47</ci_lower_limit>
            <ci_upper_limit>5.85</ci_upper_limit>
            <estimate_desc>mild attacks</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.76</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.971</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.84</ci_lower_limit>
            <ci_upper_limit>5.68</ci_upper_limit>
            <estimate_desc>moderate/severe attacks</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Attacks in Which Pain Reduction Was Achieved</title>
        <description>Percentage of attacks in which pain reduction (defined as a decrease in pain intensity of at least one point on the following scale: 0, none; 1, mild; 2, moderate; 3, severe) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.</description>
        <time_frame>10, 15, 30, 45, 60, 90, and 120 minutes</time_frame>
        <population>FAS. The LOCF imputation method was used in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan Nasal Powder</title>
            <description>Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan Tablet</title>
            <description>Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Attacks in Which Pain Reduction Was Achieved</title>
          <description>Percentage of attacks in which pain reduction (defined as a decrease in pain intensity of at least one point on the following scale: 0, none; 1, mild; 2, moderate; 3, severe) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.</description>
          <population>FAS. The LOCF imputation method was used in this analysis.</population>
          <units>percentage of attacks</units>
          <param>Number</param>
          <units_analyzed>number of attacks</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>number of attacks</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="765"/>
                <count group_id="O2" value="766"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>10 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5"/>
                    <measurement group_id="O2" value="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.4"/>
                    <measurement group_id="O2" value="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.0"/>
                    <measurement group_id="O2" value="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.7"/>
                    <measurement group_id="O2" value="49.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.2"/>
                    <measurement group_id="O2" value="59.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.6"/>
                    <measurement group_id="O2" value="69.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.0"/>
                    <measurement group_id="O2" value="75.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3549</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.60</ci_upper_limit>
            <estimate_desc>10 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0005</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.20</ci_lower_limit>
            <ci_upper_limit>1.90</ci_upper_limit>
            <estimate_desc>15 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.45</ci_lower_limit>
            <ci_upper_limit>2.21</ci_upper_limit>
            <estimate_desc>30 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.24</ci_lower_limit>
            <ci_upper_limit>1.96</ci_upper_limit>
            <estimate_desc>45 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0057</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.10</ci_lower_limit>
            <ci_upper_limit>1.71</ci_upper_limit>
            <estimate_desc>60 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0654</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>1.61</ci_upper_limit>
            <estimate_desc>90 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2894</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.49</ci_upper_limit>
            <estimate_desc>120 minutes post-dose</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Attacks in Which Pain Freedom Was Achieved</title>
        <description>Percentage of attacks in which pain freedom (defined as pain level reduced to none [Grade 0]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.</description>
        <time_frame>Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)</time_frame>
        <population>FAS. The LOCF imputation method was used for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan Nasal Powder</title>
            <description>Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan Tablet</title>
            <description>Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Attacks in Which Pain Freedom Was Achieved</title>
          <description>Percentage of attacks in which pain freedom (defined as pain level reduced to none [Grade 0]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.</description>
          <population>FAS. The LOCF imputation method was used for this analysis.</population>
          <units>percentage of attacks</units>
          <param>Number</param>
          <units_analyzed>number of attacks</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>number of attacks</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="765"/>
                <count group_id="O2" value="766"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>10 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                    <measurement group_id="O2" value="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2"/>
                    <measurement group_id="O2" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2"/>
                    <measurement group_id="O2" value="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.0"/>
                    <measurement group_id="O2" value="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.2"/>
                    <measurement group_id="O2" value="32.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.8"/>
                    <measurement group_id="O2" value="44.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.4"/>
                    <measurement group_id="O2" value="56.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1771</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>4.54</ci_upper_limit>
            <estimate_desc>10 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0077</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.21</ci_lower_limit>
            <ci_upper_limit>3.42</ci_upper_limit>
            <estimate_desc>15 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.32</ci_lower_limit>
            <ci_upper_limit>2.50</ci_upper_limit>
            <estimate_desc>30 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.29</ci_lower_limit>
            <ci_upper_limit>2.09</ci_upper_limit>
            <estimate_desc>45 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0016</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.14</ci_lower_limit>
            <ci_upper_limit>1.74</ci_upper_limit>
            <estimate_desc>60 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0059</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.09</ci_lower_limit>
            <ci_upper_limit>1.69</ci_upper_limit>
            <estimate_desc>90 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2717</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.42</ci_upper_limit>
            <estimate_desc>120 minutes post-dose</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Attacks in Which Pain Relief Was Achieved</title>
        <description>Percentage of attacks treated at a severity of moderate (Grade 2) or severe (Grade 3) in which pain relief (defined as pain level reduced to none [Grade 0] or mild [Grade 1]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.</description>
        <time_frame>Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)</time_frame>
        <population>FAS. The LOCF imputation method was used in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan Nasal Powder</title>
            <description>Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan Tablet</title>
            <description>Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Attacks in Which Pain Relief Was Achieved</title>
          <description>Percentage of attacks treated at a severity of moderate (Grade 2) or severe (Grade 3) in which pain relief (defined as pain level reduced to none [Grade 0] or mild [Grade 1]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.</description>
          <population>FAS. The LOCF imputation method was used in this analysis.</population>
          <units>percentage of attacks</units>
          <param>Number</param>
          <units_analyzed>number of moderate or severe attacks</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>number of moderate or severe attacks</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="509"/>
                <count group_id="O2" value="532"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>10 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.8"/>
                    <measurement group_id="O2" value="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.9"/>
                    <measurement group_id="O2" value="20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.8"/>
                    <measurement group_id="O2" value="38.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.0"/>
                    <measurement group_id="O2" value="53.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.1"/>
                    <measurement group_id="O2" value="62.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.4"/>
                    <measurement group_id="O2" value="72.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.6"/>
                    <measurement group_id="O2" value="76.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2426</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.77</ci_upper_limit>
            <estimate_desc>10 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0069</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.12</ci_lower_limit>
            <ci_upper_limit>1.99</ci_upper_limit>
            <estimate_desc>15 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.47</ci_lower_limit>
            <ci_upper_limit>2.56</ci_upper_limit>
            <estimate_desc>30 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0004</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.26</ci_lower_limit>
            <ci_upper_limit>2.23</ci_upper_limit>
            <estimate_desc>45 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0008</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.22</ci_lower_limit>
            <ci_upper_limit>2.11</ci_upper_limit>
            <estimate_desc>60 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0272</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>1.83</ci_upper_limit>
            <estimate_desc>90 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2085</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>1.62</ci_upper_limit>
            <estimate_desc>120 minutes post-dose</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to Pain Freedom</title>
        <description>Pain freedom is defined as a pain level reduced to none (Grade 0).</description>
        <time_frame>120 minutes post-dose (up to 24 weeks)</time_frame>
        <population>FAS. If the participant did not report pain freedom within 120 minutes post-dose, he/she was considered to be censored at the last non-missing result prior to the 120-minute time point.</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan Nasal Powder</title>
            <description>Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan Tablet</title>
            <description>Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to Pain Freedom</title>
          <description>Pain freedom is defined as a pain level reduced to none (Grade 0).</description>
          <population>FAS. If the participant did not report pain freedom within 120 minutes post-dose, he/she was considered to be censored at the last non-missing result prior to the 120-minute time point.</population>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91" lower_limit="NA" upper_limit="NA">The confidence interval is un-estimable due to the number of participants who were observed pain free at the post-dose time points.</measurement>
                    <measurement group_id="O2" value="121" lower_limit="91" upper_limit="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose</title>
        <description>Participants were required to record their headache severity score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their headaches on the following severity scale: 0, none; 1, mild; 2, moderate; 3, severe. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
        <time_frame>Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)</time_frame>
        <population>FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan Nasal Powder</title>
            <description>Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan Tablet</title>
            <description>Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose</title>
          <description>Participants were required to record their headache severity score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their headaches on the following severity scale: 0, none; 1, mild; 2, moderate; 3, severe. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
          <population>FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.</population>
          <units>scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>10 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="0.018"/>
                    <measurement group_id="O2" value="-0.09" spread="0.018"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.26" spread="0.029"/>
                    <measurement group_id="O2" value="-0.18" spread="0.029"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="0.042"/>
                    <measurement group_id="O2" value="-0.38" spread="0.042"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.77" spread="0.049"/>
                    <measurement group_id="O2" value="-0.60" spread="0.049"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.93" spread="0.051"/>
                    <measurement group_id="O2" value="-0.79" spread="0.051"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.09" spread="0.052"/>
                    <measurement group_id="O2" value="-0.98" spread="0.052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.19" spread="0.053"/>
                    <measurement group_id="O2" value="-1.15" spread="0.053"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3562</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.021</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.06</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
            <estimate_desc>10 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0063</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.029</dispersion_value>
            <ci_percent>94</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.14</ci_lower_limit>
            <ci_upper_limit>-0.02</ci_upper_limit>
            <estimate_desc>15 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.19</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.039</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.26</ci_lower_limit>
            <ci_upper_limit>-0.11</ci_upper_limit>
            <estimate_desc>30 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0005</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.046</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.26</ci_lower_limit>
            <ci_upper_limit>-0.07</ci_upper_limit>
            <estimate_desc>45 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0040</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.14</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.048</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.24</ci_lower_limit>
            <ci_upper_limit>-0.05</ci_upper_limit>
            <estimate_desc>60 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0333</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.052</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.21</ci_lower_limit>
            <ci_upper_limit>-0.01</ci_upper_limit>
            <estimate_desc>90 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4031</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.052</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.15</ci_lower_limit>
            <ci_upper_limit>0.06</ci_upper_limit>
            <estimate_desc>120 minutes post-dose</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose</title>
        <description>Participants were required to record their clinical disability score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
        <time_frame>Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)</time_frame>
        <population>FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan Nasal Powder</title>
            <description>Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan Tablet</title>
            <description>Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose</title>
          <description>Participants were required to record their clinical disability score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
          <population>FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.</population>
          <units>scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>10 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.017"/>
                    <measurement group_id="O2" value="-0.03" spread="0.017"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="0.025"/>
                    <measurement group_id="O2" value="-0.09" spread="0.025"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.42" spread="0.038"/>
                    <measurement group_id="O2" value="-0.26" spread="0.038"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.60" spread="0.046"/>
                    <measurement group_id="O2" value="-0.43" spread="0.046"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.73" spread="0.049"/>
                    <measurement group_id="O2" value="-0.56" spread="0.049"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.83" spread="0.052"/>
                    <measurement group_id="O2" value="-0.72" spread="0.052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.92" spread="0.054"/>
                    <measurement group_id="O2" value="-0.85" spread="0.054"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0181</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.019</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.08</ci_lower_limit>
            <ci_upper_limit>-0.01</ci_upper_limit>
            <estimate_desc>10 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.026</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.14</ci_lower_limit>
            <ci_upper_limit>-0.04</ci_upper_limit>
            <estimate_desc>15 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.16</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.035</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.23</ci_lower_limit>
            <ci_upper_limit>-0.09</ci_upper_limit>
            <estimate_desc>30 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.043</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.25</ci_lower_limit>
            <ci_upper_limit>-0.08</ci_upper_limit>
            <estimate_desc>45 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0006</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.16</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.047</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.26</ci_lower_limit>
            <ci_upper_limit>-0.07</ci_upper_limit>
            <estimate_desc>60 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0189</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.048</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.21</ci_lower_limit>
            <ci_upper_limit>-0.02</ci_upper_limit>
            <estimate_desc>90 minutes post-dose</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1704</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.050</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.17</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
            <estimate_desc>120 minutes post-dose</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event</title>
        <description>An adverse event is defined as any untoward medical occurrence associated with the use of an investigational product in humans, whether or not it is considered related to the investigational product. This includes any occurrence that was new in onset or aggravated in severity or frequency from the Baseline condition.</description>
        <time_frame>Baseline compared to Vist 2, 3 and 4</time_frame>
        <population>Safety Analysis Set: all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan Nasal Powder</title>
            <description>Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan Tablet</title>
            <description>Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event</title>
          <description>An adverse event is defined as any untoward medical occurrence associated with the use of an investigational product in humans, whether or not it is considered related to the investigational product. This includes any occurrence that was new in onset or aggravated in severity or frequency from the Baseline condition.</description>
          <population>Safety Analysis Set: all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="219"/>
                <count group_id="O2" value="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment-emergent Adverse Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                    <measurement group_id="O2" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-emergent Serious Adverse Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)</title>
        <description>Change from Baseline in hemoglobin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)</title>
          <description>Change from Baseline in hemoglobin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
          <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
          <units>grams per Liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="6.07"/>
                    <measurement group_id="O2" value="-1.3" spread="6.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="6.58"/>
                    <measurement group_id="O2" value="-0.8" spread="6.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)</title>
        <description>Change from Baseline in hematocrit (proportion of total blood volume that is composed of red blood cells) was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)</title>
          <description>Change from Baseline in hematocrit (proportion of total blood volume that is composed of red blood cells) was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
          <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
          <units>proportion</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3, n=108, 94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.002" spread="0.0204"/>
                    <measurement group_id="O2" value="-0.005" spread="0.0222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4, n=124, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.005" spread="0.0222"/>
                    <measurement group_id="O2" value="-0.002" spread="0.0198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
        <description>Change from Baseline in red blood cell count was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
          <description>Change from Baseline in red blood cell count was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
          <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
          <units>10^12 cells per Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3, n=109, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.227"/>
                    <measurement group_id="O2" value="-0.04" spread="0.280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4, n=124, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="0.228"/>
                    <measurement group_id="O2" value="-0.02" spread="0.209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
        <description>Change from Baseline in white blood cell (WBC) count, basinophils, monocytes, neutrophils, lymphocytes, eosinophils, and platelets was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
          <description>Change from Baseline in white blood cell (WBC) count, basinophils, monocytes, neutrophils, lymphocytes, eosinophils, and platelets was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
          <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
          <units>10^9 cells per Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>WBC Count, Visit 3, n=109, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="1.398"/>
                    <measurement group_id="O2" value="-0.19" spread="1.381"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC Count, Visit 4, n=124, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="1.477"/>
                    <measurement group_id="O2" value="-0.09" spread="1.464"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils, Visit 3, n=108, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" spread="0.0301"/>
                    <measurement group_id="O2" value="0.000" spread="0.0297"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils, Visit 4, n=124, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" spread="0.0283"/>
                    <measurement group_id="O2" value="-0.001" spread="0.0235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes, Visit 3, n=108, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.030" spread="0.1356"/>
                    <measurement group_id="O2" value="-0.022" spread="0.1160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes, Visit 4, n=124, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.014" spread="0.1504"/>
                    <measurement group_id="O2" value="-0.026" spread="0.1281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, Visit 3, n=108, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.052" spread="1.2553"/>
                    <measurement group_id="O2" value="-0.134" spread="1.1600"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, Visit 4, n=124, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.059" spread="1.4270"/>
                    <measurement group_id="O2" value="-0.057" spread="1.2885"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, Visit 3, n=108, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.049" spread="0.4702"/>
                    <measurement group_id="O2" value="-0.038" spread="0.3892"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, Visit 4, n=124, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.012" spread="0.4252"/>
                    <measurement group_id="O2" value="-0.020" spread="0.3925"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, Visit 3, n=108, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.001" spread="0.0766"/>
                    <measurement group_id="O2" value="0.006" spread="0.0493"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, Visit 4, n=124, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.012" spread="0.1068"/>
                    <measurement group_id="O2" value="0.013" spread="0.0824"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets, Visit 3, n=109, 93</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" spread="29.14"/>
                    <measurement group_id="O2" value="-8.2" spread="46.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets, Visit 4, n=123, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.0" spread="27.92"/>
                    <measurement group_id="O2" value="-7.5" spread="43.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
        <description>Change from Baseline in urea was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
          <description>Change from Baseline in urea was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
          <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
          <units>millimoles per Liter (mmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3, n=108, 94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.070" spread="1.2118"/>
                    <measurement group_id="O2" value="0.079" spread="1.2227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4, n=123, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.156" spread="1.2840"/>
                    <measurement group_id="O2" value="0.308" spread="1.3674"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
        <description>Change from Baseline in creatinine was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
          <description>Change from Baseline in creatinine was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
          <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
          <units>micromoles per Liter (µmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3, n=108, 94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" spread="10.73"/>
                    <measurement group_id="O2" value="-0.7" spread="6.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4, n=123, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="11.77"/>
                    <measurement group_id="O2" value="-0.6" spread="8.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
        <description>Change from Baseline in ALP and ALT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
          <description>Change from Baseline in ALP and ALT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
          <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
          <units>International Units per Liter (IU/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALP, Visit 3, n=108, 94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="8.92"/>
                    <measurement group_id="O2" value="0.0" spread="6.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP, Visit 4, n=123, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="9.92"/>
                    <measurement group_id="O2" value="-1.0" spread="9.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT, Visit 3, n=108, 94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="7.08"/>
                    <measurement group_id="O2" value="0.0" spread="8.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT, Visit 4, n=123, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="6.83"/>
                    <measurement group_id="O2" value="-0.9" spread="7.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
        <description>Change from Baseline in AST and GGT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
          <description>Change from Baseline in AST and GGT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
          <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
          <units>International Units per Liter (IU/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AST, Visit 3, n=108, 92</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="5.26"/>
                    <measurement group_id="O2" value="0.5" spread="14.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST, Visit 4, n=123, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="7.88"/>
                    <measurement group_id="O2" value="-1.2" spread="5.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GGT, Visit 3, n=108, 94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="10.09"/>
                    <measurement group_id="O2" value="0.0" spread="7.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GGT, Visit 4, n=123, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="10.31"/>
                    <measurement group_id="O2" value="-0.7" spread="7.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
        <description>Change from Baseline in total bilirubin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
          <description>Change from Baseline in total bilirubin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
          <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
          <units>Units per Liter (U/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3, n=108, 94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="4.26"/>
                    <measurement group_id="O2" value="-0.2" spread="2.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4, n=123, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="4.09"/>
                    <measurement group_id="O2" value="0.2" spread="4.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
        <description>Change from Baseline in albumin and total protein was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
          <description>Change from Baseline in albumin and total protein was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
          <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
          <units>grams per Liter (grams/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>albumin, Visit 3, n=108, 94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="2.82"/>
                    <measurement group_id="O2" value="-0.9" spread="2.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>albumin, Visit 4, n=123, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="2.98"/>
                    <measurement group_id="O2" value="-0.5" spread="2.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>total protein, Visit 3, n=108, 94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="3.75"/>
                    <measurement group_id="O2" value="-1.2" spread="3.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>total protein, Visit 4, n=122, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="4.20"/>
                    <measurement group_id="O2" value="-1.0" spread="3.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
        <description>Change from Baseline in sodium, potassium, chloride, calcium, and glucose was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
          <description>Change from Baseline in sodium, potassium, chloride, calcium, and glucose was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
          <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
          <units>mmoles/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>sodium, Visit 3, n=108, 94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="2.62"/>
                    <measurement group_id="O2" value="-0.5" spread="2.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>sodium, Visit 4, n=122, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="2.76"/>
                    <measurement group_id="O2" value="-0.2" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>potassium, Visit 3, n=108, 94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.440"/>
                    <measurement group_id="O2" value="-0.04" spread="0.404"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>potassium, Visit 4, n=122, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.411"/>
                    <measurement group_id="O2" value="-0.00" spread="0.406"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>chloride, Visit 3, n=108, 94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="2.95"/>
                    <measurement group_id="O2" value="0.0" spread="2.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>chloride, Visit 4, n=122, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="2.62"/>
                    <measurement group_id="O2" value="0.2" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>calcium, Visit 3, n=108, 94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.019" spread="0.1017"/>
                    <measurement group_id="O2" value="-0.016" spread="0.1043"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>calcium, Visit 4, n=123, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.011" spread="0.1058"/>
                    <measurement group_id="O2" value="-0.006" spread="0.0886"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>glucose, Visit 3, n=108, 94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="1.316"/>
                    <measurement group_id="O2" value="0.05" spread="0.930"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>glucose, Visit 4, n=123, 110</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="1.063"/>
                    <measurement group_id="O2" value="0.24" spread="1.135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
        <description>Change from Baseline in urinalysis values was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
          <description>Change from Baseline in urinalysis values was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
          <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3, n=108, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.603"/>
                    <measurement group_id="O2" value="-0.03" spread="0.720"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4, n=124, 109</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.664"/>
                    <measurement group_id="O2" value="-0.07" spread="0.658"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)</title>
        <description>The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Data are based on standard reads, with &quot;1+,&quot; &quot;2+,&quot; and &quot;3+&quot; indicating increasing amounts of metabolites in urine.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)</title>
          <description>The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Data are based on standard reads, with &quot;1+,&quot; &quot;2+,&quot; and &quot;3+&quot; indicating increasing amounts of metabolites in urine.</description>
          <population>Safety Analysis Set</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Protein, Baseline, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112"/>
                    <measurement group_id="O2" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Baseline, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Baseline, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Baseline, 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Visit 3, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Visit 3, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Visit 3, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Visit 3, 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Visit 4, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Visit 4, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Visit 4, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Visit 4, 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Baseline, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132"/>
                    <measurement group_id="O2" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Baseline, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Baseline, 3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Visit 3, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                    <measurement group_id="O2" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Visit 3, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Visit 3, 3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Visit 4, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                    <measurement group_id="O2" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Visit 4, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Visit 4, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Visit 4, 3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, Baseline, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124"/>
                    <measurement group_id="O2" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, Baseline, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, Baseline, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, Baseline, 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, Visit 3, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, Visit 3, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, Visit 3, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, Visit 3, 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, Visit 4, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                    <measurement group_id="O2" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, Visit 4, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, Visit 4, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Baseline, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116"/>
                    <measurement group_id="O2" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Baseline, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Baseline, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Baseline, 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Baseline, 3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Visit 3, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Visit 3, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Visit 3, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Visit 3, 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Visit 3, 3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Visit 4, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111"/>
                    <measurement group_id="O2" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Visit 4, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Visit 4, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Visit 4, 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood, Visit 4, 3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Baseline, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Baseline, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Baseline, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Baseline, 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Baseline, 3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Visit 3, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Visit 3, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Visit 3, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Visit 3, 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Visit 3, 3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Visit 4, negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Visit 4, trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Visit 4, 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Visit 4, 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBCs, Visit 4, 3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
        <description>Change from Baseline in SBP and DBP was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
          <description>Change from Baseline in SBP and DBP was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
          <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
          <units>millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP, Visit 3, n=110, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="11.58"/>
                    <measurement group_id="O2" value="1.5" spread="11.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, Visit 4, n=124, 111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="11.52"/>
                    <measurement group_id="O2" value="2.0" spread="11.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Visit 3, n=110, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="7.17"/>
                    <measurement group_id="O2" value="1.0" spread="8.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Visit 4, n=124, 111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="7.42"/>
                    <measurement group_id="O2" value="-0.2" spread="7.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
        <description>Change from Baseline in pulse was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)</title>
          <description>Change from Baseline in pulse was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.</description>
          <population>Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3, n=110, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="8.63"/>
                    <measurement group_id="O2" value="0.1" spread="9.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4, n=124, 111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" spread="9.07"/>
                    <measurement group_id="O2" value="-0.2" spread="10.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)</title>
        <description>The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). A categorization of &quot;normal&quot; or &quot;abnormal&quot; was made per the investigators' clinical judgment of the ECG, taking the participants' demographic characteristics and other medical conditions into account. CS = clinically significant. CNS = clinically not significant.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)</title>
          <description>The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). A categorization of &quot;normal&quot; or &quot;abnormal&quot; was made per the investigators' clinical judgment of the ECG, taking the participants' demographic characteristics and other medical conditions into account. CS = clinically significant. CNS = clinically not significant.</description>
          <population>Safety Analysis Set</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, normal; n=133, 129</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, abnormal, CS; n=133, 129</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, abnormal, CNS; n=133, 129</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3, normal; n=110, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3, abnormal, CS; n=110, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3, abnormal, CNS; n=110, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4, normal; n=124, 111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4, abnormal, CS; n=124, 111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4, abnormal, CNS; n=123, 111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)</title>
        <description>The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). CS = clinically significant. CNS = clinically not significant.</description>
        <time_frame>Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)</title>
          <description>The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). CS = clinically significant. CNS = clinically not significant.</description>
          <population>Safety Analysis Set</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, CS; n=133, 129</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, CNS; n=133, 129</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132"/>
                    <measurement group_id="O2" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3, CS; n=110, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3, CNS; n=110, 95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                    <measurement group_id="O2" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4, CS; n=124, 111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4, CNS; n=124, 111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124"/>
                    <measurement group_id="O2" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With the Indicated Concomitant Medications</title>
        <description>Concomitant medications are defined as non-study medications with a start or stop date between the first dose of study medication and the end of safety follow-up, inclusive. Derm. = dermatologic; incl. - including.</description>
        <time_frame>up to 24 weeks</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
          <group group_id="O2">
            <title>100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)</title>
            <description>In Treatment Period 1 (&lt;=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (&lt;=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat &lt;=5 qualifying migraine headaches during Treatment Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With the Indicated Concomitant Medications</title>
          <description>Concomitant medications are defined as non-study medications with a start or stop date between the first dose of study medication and the end of safety follow-up, inclusive. Derm. = dermatologic; incl. - including.</description>
          <population>Safety Analysis Set</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="219"/>
                <count group_id="O2" value="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any concomitant medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="218"/>
                    <measurement group_id="O2" value="226"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agents acting on the renin-angiotensin system</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other therapeutic products</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Allergens</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anabolic agents for systemic use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Analgesics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143"/>
                    <measurement group_id="O2" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anesthetics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-acne preparations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-Parkinson drugs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antianemic preparations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antibacterials for systemic use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antibiotics and chemotherapeutics for derm. use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antidiarrrheals, intestinal antiinflammatories</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antiemetics and antinauseants</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antiepileptics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antigout preparations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antihistamines for systemic use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antiinflammatory and antirheumatic products</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                    <measurement group_id="O2" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antimyotics for systemic use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antiobesity preparations, exluding diet products</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antiprotozoals</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antiseptics and disinfectants</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antithrombotic agents</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antivirals for systemic use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Beta blocking agents</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium channel blockers</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corticosteroids for systemic use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corticosteroids, dermatologic preparations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cough and cold preparations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diuretics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drugs for acid related disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drugs for functional gastrointestinal disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drugs for obstructive airways diseases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drugs for treatment of bone diseases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drugs used in diabetes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ectoparasiticides, incl. scabacides, insecticides</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gynecological antiinfectives and antiseptics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immune sera and immunoglobulins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Laxatives</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipid modifying agents</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mineral supplements</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle relaxants</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nasal preparations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Opthalmologicals</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other alimentary tract and metabolism products</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other dermatological preparations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other gynecologicals</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other nervous system drugs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Otologicals</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychoanaleptics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psycholeptics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sex hormones and modulators of the genital system</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thyroid therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unspecified herbal and traditional medicine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urologicals</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccines</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vitamins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.</time_frame>
      <desc>Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.</desc>
      <group_list>
        <group group_id="E1">
          <title>20 mg Sumatriptan Nasal Powder</title>
          <description>Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.</description>
        </group>
        <group group_id="E2">
          <title>100 mg Sumatriptan Tablet</title>
          <description>Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.</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="219"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="228"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA (14.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="98" subjects_at_risk="219"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="228"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="219"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="228"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Product taste abnormal</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="219"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="228"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="228"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="228"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="219"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="228"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="219"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="228"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="219"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="228"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="219"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="228"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="219"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="228"/>
              </event>
              <event>
                <sub_title>Rhinalgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="219"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="228"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="219"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="228"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="219"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="228"/>
              </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>Nadine Knowles; Executive Director, Research &amp; Development Operations</name_or_title>
      <organization>Avanir Pharmaceuticals</organization>
      <phone>1-949-268-8972</phone>
      <email>nknowles@avanir.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/NCT01667679
org study id: OPN-SUM-MIG-3302
nct id: NCT01667679
lead sponsor: 
has dmc: No
This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through
      the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with migraine
      headaches in 30 minutes after use.
The primary objective for this study is to compare the proportion of attacks in which pain
      reduction (defined as a decrease in pain intensity of at least 1 point) is achieved at 30
      minutes following 20 mg OPTINOSE SUMATRIPTAN treatment with 100 mg Sumatriptan Tablets
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean Sum of Migraine Pain Intensity Differences (SPID)-30
time frame: Baseline and 30 minutes post-dose (up to 24 weeks)
description: SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild, moderate, or severe. The range of possible scores is -60 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of "0" indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an analysis of covariance (ANCOVA) model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The Last Observation Carried Forward (LOCF) imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.
measure: Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe
time frame: Baseline and 30 minutes post-dose (up to 24 weeks)
description: SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild and moderate/severe (rated on a 4-point scale: 0=none, 1=mild, 2=moderate, and 3=severe). The range of possible scores for all participants is -60 to +90. For participants with a mild headache at Baseline, the SPID range is -60 to +30. For participants with a moderate/severe headache at Baseline, the SPID range is -30 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of "0" indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The LOCF imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.
measure: Percentage of Attacks in Which Pain Reduction Was Achieved
time frame: 10, 15, 30, 45, 60, 90, and 120 minutes
description: Percentage of attacks in which pain reduction (defined as a decrease in pain intensity of at least one point on the following scale: 0, none; 1, mild; 2, moderate; 3, severe) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.
measure: Percentage of Attacks in Which Pain Freedom Was Achieved
time frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
description: Percentage of attacks in which pain freedom (defined as pain level reduced to none [Grade 0]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.
measure: Percentage of Attacks in Which Pain Relief Was Achieved
time frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
description: Percentage of attacks treated at a severity of moderate (Grade 2) or severe (Grade 3) in which pain relief (defined as pain level reduced to none [Grade 0] or mild [Grade 1]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.
measure: Median Time to Pain Freedom
time frame: 120 minutes post-dose (up to 24 weeks)
description: Pain freedom is defined as a pain level reduced to none (Grade 0).
measure: Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
time frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
description: Participants were required to record their headache severity score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their headaches on the following severity scale: 0, none; 1, mild; 2, moderate; 3, severe. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.
measure: Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
time frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
description: Participants were required to record their clinical disability score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.
measure: Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event
time frame: Baseline compared to Vist 2, 3 and 4
description: An adverse event is defined as any untoward medical occurrence associated with the use of an investigational product in humans, whether or not it is considered related to the investigational product. This includes any occurrence that was new in onset or aggravated in severity or frequency from the Baseline condition.
measure: Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: Change from Baseline in hemoglobin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
measure: Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: Change from Baseline in hematocrit (proportion of total blood volume that is composed of red blood cells) was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
measure: Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: Change from Baseline in red blood cell count was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
measure: Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: Change from Baseline in white blood cell (WBC) count, basinophils, monocytes, neutrophils, lymphocytes, eosinophils, and platelets was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
measure: Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: Change from Baseline in urea was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
measure: Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: Change from Baseline in creatinine was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
measure: Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: Change from Baseline in ALP and ALT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
measure: Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: Change from Baseline in AST and GGT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
measure: Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: Change from Baseline in total bilirubin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
measure: Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: Change from Baseline in albumin and total protein was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
measure: Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: Change from Baseline in sodium, potassium, chloride, calcium, and glucose was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
measure: Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: Change from Baseline in urinalysis values was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
measure: Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Data are based on standard reads, with "1+," "2+," and "3+" indicating increasing amounts of metabolites in urine.
measure: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: Change from Baseline in SBP and DBP was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
measure: Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: Change from Baseline in pulse was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
measure: Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). A categorization of "normal" or "abnormal" was made per the investigators' clinical judgment of the ECG, taking the participants' demographic characteristics and other medical conditions into account. CS = clinically significant. CNS = clinically not significant.
measure: Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
description: The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). CS = clinically significant. CNS = clinically not significant.
measure: Number of Participants With the Indicated Concomitant Medications
time frame: up to 24 weeks
description: Concomitant medications are defined as non-study medications with a start or stop date between the first dose of study medication and the end of safety follow-up, inclusive. Derm. = dermatologic; incl. - including.
arm group label: OPTINOSE SUMATRIPTAN and Placebo
arm group type: Experimental
description: 20 mg OPTINOSE SUMATRIPTAN Powder Delivered Intranasally With the Bi-directional Device nasally and Placebo Tablet
arm group label: 100mg Sumatriptan and OPTINOSE Placebo
arm group type: Active Comparator
description: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally
intervention type: Drug
intervention name: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally
arm group label: 100mg Sumatriptan and OPTINOSE Placebo
intervention type: Drug
intervention name: OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet
arm group label: OPTINOSE SUMATRIPTAN and Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Headache
mesh term: Sumatriptan
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 