<clinical_study>
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  <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/NCT02991859</url>
  </required_header>
  <id_info>
    <org_study_id>203162</org_study_id>
    <secondary_id>2016-003002-14</secondary_id>
    <nct_id>NCT02991859</nct_id>
  </id_info>
  <brief_title>Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects</brief_title>
  <official_title>An Escalating Dose, Randomized, Placebo-controlled, Incomplete-block, 2-period Cross-over Study to Assess the Dose Response for Topical Efficacy Via Airway Responsiveness to Adenosine-5'-Monophosphate (AMP) Challenge and the Dose Response for Systemic Activity Via 24h Plasma Cortisol Suppression and Thereby the Relative Therapeutic Index for Fluticasone Furoate (FF), Fluticasone Propionate (FP) and Budesonide (BUD) in Asthmatic Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, placebo-controlled, 2-period crossover, escalating repeat dose study,&#xD;
      aiming to investigate whether higher potency of different inhaled corticosteroid confers an&#xD;
      improvement in the topical efficacy to systemic activity ratio in asthmatic subjects. It will&#xD;
      compare the dose response for topical efficacy via airway responsiveness (to&#xD;
      adenosine-5'-monophosphate [AMP] challenge), and the dose response for systemic activity via&#xD;
      24 hour plasma cortisol suppression, and thereby compare the relative therapeutic index, for&#xD;
      the following inhaled corticosteroids: fluticasone furoate (FF), fluticasone propionate (FP)&#xD;
      and budesonide (BUD). There will be a screening visit 4 - 42 days before the first dose of&#xD;
      study treatment, and AMP challenge Provocative concentration 20 (PC20) of &lt;=80 milligrams per&#xD;
      milliliter (mg/mL) at screening visit 2 i.e. at 4 - 14 days before the first dose of study&#xD;
      treatment. Subjects will be randomized to one of 5 or 12 treatment sequences, and will have&#xD;
      one or two treatment periods, each comprising 5 consecutive 7-day phases of escalating doses&#xD;
      of either FF, FP, BUD or placebo. There will be a 25- to 42-day washout period between&#xD;
      treatment periods. The study duration for each subject will be approximately 13 or 24 weeks&#xD;
      including the follow-up period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 9, 2017</start_date>
  <completion_date type="Actual">December 20, 2018</completion_date>
  <primary_completion_date type="Actual">December 20, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis</measure>
    <time_frame>12 hours post last dose on Day 7</time_frame>
    <description>The percentage fall in FEV1 was calculated using highest FEV1 (post saline) minus highest FEV1 (post AMP) divided by highest FEV1 (post saline)*100 where highest FEV1 (post saline) is the highest value of two FEV1 measurements at 60 and 180 seconds after the saline control, highest FEV1 (post AMP) is the highest value of the two FEV1 measurements at 60 and 180 seconds after the dose of AMP. Results are presented treatment wise. The analysis method was a 3 parameter Emax model with log 2 transformed AMP PC20 as the outcome variable, assuming common Emax across FF, FP and BUD, and with an unstructured variance-covariance matrix. Mean and 95% Confidence Interval (CI) presented are predicted estimate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cortisol Suppression 0-24 Hours Weighted Mean-Dose Response Analysis</measure>
    <time_frame>Pre-dose PM dose on Day 6 to pre-dose PM dose Day 7</time_frame>
    <description>Blood samples for measurement of plasma cortisol were collected at given time point. The weighted means were derived by calculating the area under the curve (AUC) over the 0-24-hour period using the trapezoidal rule, and then dividing it by the actual time interval. Results are presented treatment wise. Mean and 95% CI presented are predicted estimate. The analysis method was an inhibitory exponential power-law model with log e transformed cortisol as the outcome variable, assuming 100% inhibition at highest doses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Theraputic Index of FF</measure>
    <time_frame>12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7</time_frame>
    <description>Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by Dose at which 80% of the maximum effect is reached (ED80) for AMP PC20 for FF 25 mcg, FF 100 mcg, FF 200 mcg, FF 400 mcg, FF 800 mcg. Theraputic index has been presented. Only those participants with data available at the specified time points were analyzed. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Theraputic Index of FP</measure>
    <time_frame>12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7</time_frame>
    <description>Therapeutic Index was calculated by Dose at which 20% of the maximum effect is reached (ED20) for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by ED80 for AMP PC20 for FP 50 mcg, FP 200 mcg, FP 500 mcg, FP 1000 mcg, FP 2000 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Theraputic Index of BUD</measure>
    <time_frame>12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7</time_frame>
    <description>Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by ED80 for AMP PC20 for BUD 100 mcg, BUD 400 mcg, BUD 800 mcg, BUD 1600 mcg, BUD 3200 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)</measure>
    <time_frame>Up to Week 18</time_frame>
    <description>An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that at any dose results in death, Is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1</measure>
    <time_frame>Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability of Placebo in Period 2</measure>
    <time_frame>Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in Period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1</measure>
    <time_frame>Day 2,3,4,5,6,7 PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2</measure>
    <time_frame>Day 2,3,4,5,6,7 PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1</measure>
    <time_frame>Day 8,9,10,11,12,13,14 PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2</measure>
    <time_frame>Day 8,9,10,11,12,13,14 PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1</measure>
    <time_frame>Day 15,16,17,18,19,20,21 PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2</measure>
    <time_frame>Day 15,16,17,18,19,20 PM, Day 21 AM and PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1</measure>
    <time_frame>Days 22,23,24,25,26,27,28 PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2</measure>
    <time_frame>Days 22,23,24,25,26,27,28 PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1</measure>
    <time_frame>Days 29,30,31,32,33,34,35 PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2</measure>
    <time_frame>Day 29,30,31,32,33,34,35 PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 1</measure>
    <time_frame>Day 2,3,4,5,6,7 PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2</measure>
    <time_frame>Day 2,3,4,5,6,7 AM and PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1</measure>
    <time_frame>Days 8,9,1,0,11,12,13,14 AM and PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2</measure>
    <time_frame>Day 8,9,1,0,11,12,13,14 AM and PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1</measure>
    <time_frame>Day 15 PM, Day 16,17,18,19,20,21,22,23,24,25,26,27,28 AM and PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2</measure>
    <time_frame>Day 15 PM, Day 16,17,18,19,20,21 AM and PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1</measure>
    <time_frame>Day 22 PM, Day 23,24,25,26,27,28,29,30,31,32,33,34,35 AM and PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2</measure>
    <time_frame>Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1</measure>
    <time_frame>Day 29 PM, Day 30,31,32,33,34,35 AM and PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2</measure>
    <time_frame>Day 29 PM, Day 30,31,32,33,34,35 AM and PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1</measure>
    <time_frame>Day 2 to 6 AM and PM, Day 7 PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 2</measure>
    <time_frame>Day 2,3,4,5,6,7 PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1</measure>
    <time_frame>Day 8 PM, Day 9 to 14 AM and PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2</measure>
    <time_frame>Day 8 PM, Day 9 to 14 AM and PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1</measure>
    <time_frame>Day 15,16, 17, 18, 19, 20, 21 AM and PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2</measure>
    <time_frame>Day 15 PM, Day 16, 17, 18, 19, 20, 21 AM and PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1</measure>
    <time_frame>Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2</measure>
    <time_frame>Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1</measure>
    <time_frame>Day 29 PM, Day 30, 31,32,33,34,35 AM and PM in period 1</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2</measure>
    <time_frame>Day 29 PM, Day 30, 31,32,33,34,35 AM and PM in period 2</time_frame>
    <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Abnormal Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</measure>
    <time_frame>Up to Week 18</time_frame>
    <description>SBP and DBP were measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Abnormal Vital Signs: Pulse Rate</measure>
    <time_frame>Up to Week 18</time_frame>
    <description>Pulse rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Abnormal Vital Signs: Respiratory Rate</measure>
    <time_frame>Up to Week 18</time_frame>
    <description>Respiratory rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Abnormal Vital Signs: Temperature</measure>
    <time_frame>Up to Week 18</time_frame>
    <description>Temperature was measured after participants have been rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Physical Examination</measure>
    <time_frame>Up to Week 18</time_frame>
    <description>Physical examinations included assessment of the cardiovascular, respiratory, gastrointestinal, skin, abdomen (liver and spleen), and neurological systems. This analysis was planned and data was not collected and captured in the database. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Abnormal Hematology Parameters</measure>
    <time_frame>Up to Week 18</time_frame>
    <description>Blood samples were collected for assessement of following hematology parameters: basophils, eosinophils, Erythrocyte mean corpuscular volume (MCV), hemoglobin, hematocrit, Erythrocyte mean corpuscular hemoglobin (MCH), leukocytes, lymphocytes, monocytes, platelets. Results are presented treatment wise. Only participants with clinically significant abnormal hematology data was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Abnormal Chemistry Parameters</measure>
    <time_frame>Up to Week 18</time_frame>
    <description>Blood samples were collecte for assessment of following chemistry parametres:Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, direct bilirubin, potassium, protein, sodium, urea. Results are presented treatment wise. Only participants with clinically significant abnormal chemistry data was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Abnormal Urinalysis Parameters</measure>
    <time_frame>Up to Week 18</time_frame>
    <description>Urine sample were collected to assess following urine parameters: potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick. Results are presented treatment wise. Only participants with clinically significant abnormal urinalysis data was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Expiratory Volume in 1 Second (FEV 1) in Period 1</measure>
    <time_frame>Day 1 (pre-dose) in Period 1</time_frame>
    <description>FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with American Thoracic Society (ATS) guidelines using European Respiratory Society (ERS)guidelines for predicted values. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Expiratory Volume in 1 Second (FEV 1) in Period 2</measure>
    <time_frame>Day 1 (pre-dose) in Period 2</time_frame>
    <description>FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Vital Capacity (FVC) in Period 1</measure>
    <time_frame>Day 1 (pre-dose) in Period 1</time_frame>
    <description>FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Vital Capacity (FVC) in Period 2</measure>
    <time_frame>Day 1 (pre-dose) in Period 2</time_frame>
    <description>FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.</description>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Arm AB - FF followed by FP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each treatment period (TP) comprises of 5 consecutive 7-day dosing phases with escalating doses of either FF or FP. In TP 1, subjects will receive evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period will be of 25-42 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm AC - FF followed by BUD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FF or BUD. In TP 1, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD = 100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD = 1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period will be of 25-42 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm AD - FF followed by ELLIPTA Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FF or ELLIPTA Placebo. In TP 1, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. Washout period will be of 25-42 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm BA - FP followed by FF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FP or FF. In TP 1, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period will be of 25-42 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm BC - FP followed by BUD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FP or BUD. In TP 1, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period will be of 25-42 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm BE - FP followed by DISKUS Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FP or DISKUS Placebo. In TP 1, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Each TP will be followed by a washout period of 25-42 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm CA - BUD followed by FF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either BUD or FF. In TP 1, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period will be of 25-42 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm CB - BUD followed by FP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either BUD or FP. In TP 1, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD =500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period will be of 25-42 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm CE - BUD followed by DISKUS Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either BUD or DISKUS Placebo. In TP 1, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; and AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Washout period will be of 25-42 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm DA - ELLIPTA Placebo followed by FF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either ELLIPTA Placebo or FF. In TP 1, subjects will receive PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period will be of 25-42 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm EB - DISKUS Placebo followed by FP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either DISKUS Placebo or FP. TP 1, subjects will receive PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each of DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period will be of 25-42 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm DC - ELLIPTA Placebo followed by BUD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either ELLIPTA Placebo or BUD. In TP 1, subjects will receive PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period will be of 25-42 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluticasone furoate (FF) Dry Powder Inhaler</intervention_name>
    <description>Dry inhalation powder 25 mcg, 100 mcg, and 200 mcg per blister strip will be administered using ELLIPTA for both treatment periods</description>
    <arm_group_label>Arm AB - FF followed by FP</arm_group_label>
    <arm_group_label>Arm AC - FF followed by BUD</arm_group_label>
    <arm_group_label>Arm AD - FF followed by ELLIPTA Placebo</arm_group_label>
    <arm_group_label>Arm BA - FP followed by FF</arm_group_label>
    <arm_group_label>Arm CA - BUD followed by FF</arm_group_label>
    <arm_group_label>Arm DA - ELLIPTA Placebo followed by FF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluticasone propionate (FP) Dry Powder Inhaler</intervention_name>
    <description>Dry Inhalation powder 50 mcg, 100 mcg, 250 mcg, and 500 mcg per blister strip will be administered using DISKUS for both treatment periods</description>
    <arm_group_label>Arm AB - FF followed by FP</arm_group_label>
    <arm_group_label>Arm BA - FP followed by FF</arm_group_label>
    <arm_group_label>Arm BC - FP followed by BUD</arm_group_label>
    <arm_group_label>Arm BE - FP followed by DISKUS Placebo</arm_group_label>
    <arm_group_label>Arm CB - BUD followed by FP</arm_group_label>
    <arm_group_label>Arm EB - DISKUS Placebo followed by FP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Budesonide (BUD) Turbuhaler</intervention_name>
    <description>Budesonide comprises white to off-white rounded granules, which disintegrate to a fine powder upon slight pressure, will be administered using Turbuhaler for both treatment periods.</description>
    <arm_group_label>Arm AC - FF followed by BUD</arm_group_label>
    <arm_group_label>Arm BC - FP followed by BUD</arm_group_label>
    <arm_group_label>Arm CA - BUD followed by FF</arm_group_label>
    <arm_group_label>Arm CB - BUD followed by FP</arm_group_label>
    <arm_group_label>Arm CE - BUD followed by DISKUS Placebo</arm_group_label>
    <arm_group_label>Arm DC - ELLIPTA Placebo followed by BUD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (ELLIPTA or DISKUS)</intervention_name>
    <description>Lactose dry powder inhaler will be administered using ELLIPTA or DISKUS for both treatment periods.</description>
    <arm_group_label>Arm AD - FF followed by ELLIPTA Placebo</arm_group_label>
    <arm_group_label>Arm BE - FP followed by DISKUS Placebo</arm_group_label>
    <arm_group_label>Arm CE - BUD followed by DISKUS Placebo</arm_group_label>
    <arm_group_label>Arm DA - ELLIPTA Placebo followed by FF</arm_group_label>
    <arm_group_label>Arm DC - ELLIPTA Placebo followed by BUD</arm_group_label>
    <arm_group_label>Arm EB - DISKUS Placebo followed by FP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria - Subjects must be 18 to 65 years of age inclusive, at the time of&#xD;
        signing the informed Consent. - Documented history of bronchial asthma, first diagnosed at&#xD;
        least 6 months prior to the screening visit - Pre-bronchodilator FEV1 &gt;=65% of predicted at&#xD;
        screening; the pre-dose baseline FEV1 should not have changed significantly in the opinion&#xD;
        of the investigator from the screening baseline value and should be &gt;=65% predicted for the&#xD;
        subject to continue - Documented sensitivity to AMP with a provocative concentration of AMP&#xD;
        resulting in a fall of &gt;=20% FEV1 with a PC20 AMP &lt;=80 mg/mL at the screening visit -&#xD;
        Current therapy could include short-acting Beta2-agonists (SABA) prescribed SABA for at&#xD;
        least 12 weeks prior to screening, if needed; subjects receiving low-dose ICS may take part&#xD;
        after a 4-week ICS washout prior to AMP challenge. The subject's asthma symptoms must&#xD;
        remain stable during this 4-week period as assessed at screening visit 2. Stable asthma is&#xD;
        defined as no more than 2 consecutive days where &gt;=12 inhalations/day of salbutamol were&#xD;
        used; or no severe asthma exacerbations requiring use of systemic corticosteroids (tablets,&#xD;
        suspension, or injection) or an in-patient hospitalization or emergency department visit&#xD;
        due to asthma that required systemic corticosteroids; or no clinical asthma worsening which&#xD;
        in the opinion of the investigator requires additional asthma treatment other than study&#xD;
        medication or salbutamol; subjects taking Long-acting beta2-agonist (LABA), long-acting&#xD;
        muscarinic antagonist (LAMA), leukotriene receptor antagonist (LTRA) therapy within three&#xD;
        months prior to the start of the study are not eligible; subjects taking biological&#xD;
        therapies within 6 months prior to start of the study are not eligible. - Bodyweight &gt;=50&#xD;
        Kilogram (kg) and BMI within the range 18.0-35.0 kg/meter (m)^2 (inclusive) - Male and&#xD;
        female. Females: A female subject is eligible to participate if she is not pregnant (as&#xD;
        confirmed by a negative urine human chorionic gonadotrophin [HCG] test), not lactating, and&#xD;
        at least one of the following conditions applies prior to randomization: • Non-reproductive&#xD;
        potential defined as pre-menopausal females with one of the following: Documented tubal&#xD;
        ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of&#xD;
        bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy; Postmenopausal&#xD;
        defined as 12 months of spontaneous amenorrhea, in questionable cases a blood sample with&#xD;
        simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with&#xD;
        menopause. Females on hormone replacement therapy (HRT) and whose menopausal status is in&#xD;
        doubt will be required to use one of the highly effective contraception methods if they&#xD;
        wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow&#xD;
        confirmation of post-menopausal status prior to study enrolment. • Reproductive potential&#xD;
        and agrees to follow one of the highly effective methods for avoiding pregnancy in females&#xD;
        of reproductive potential from 30 days prior to the first dose of study medication and&#xD;
        until at least five terminal half-lives after the last dose of study medication. The&#xD;
        investigator is responsible for ensuring that subjects understand how to properly use these&#xD;
        methods of contraception. - Aspartate aminotransferase and Alanine transaminase &lt;2x upper&#xD;
        limit of normal (ULN); alkaline phosphatase and bilirubin ≤1.5 x ULN (isolated bilirubin&#xD;
        &gt;1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin &lt;35%) - Light&#xD;
        smokers, who smoke &lt;=20 cigarettes per week or equivalent unit dose of other tobacco&#xD;
        products or e-cigarettes, are eligible for the study. Smokers who intend to stop, reduce or&#xD;
        increase their smoking habit during the study period are not eligible. - Having provided&#xD;
        written informed consent, which includes compliance with the requirements and restrictions&#xD;
        listed in the consent form.&#xD;
&#xD;
        Exclusion Criteria: - A history of life-threatening asthma, defined as an asthma episode&#xD;
        that required intubation and/or was associated with hypercapnia, respiratory arrest or&#xD;
        hypoxic seizures within the last 5 years. - Other significant pulmonary diseases to include&#xD;
        (but not limited to) severe pneumonia within 6 months of the screening visit, pneumothorax,&#xD;
        atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis,&#xD;
        emphysema, chronic obstructive pulmonary disease, tuberculosis or other respiratory&#xD;
        abnormalities other than asthma. - Culture-documented or suspected bacterial or viral&#xD;
        infection of the upper or lower respiratory tract, sinus or middle ear within 4 weeks of&#xD;
        screening that: In the opinion of the investigator, is expected to affect the subject's&#xD;
        asthma status or the subject's ability to participate in the study. - A subject will not be&#xD;
        eligible if he/she has clinical visual evidence of oral candidiasis at screening. - Any&#xD;
        asthma exacerbation requiring oral corticosteroids within 12 weeks of screening or that&#xD;
        resulted in overnight hospitalization requiring additional treatment for asthma within 6&#xD;
        months prior to randomization. - Use of prohibited medications including, anti-depressant&#xD;
        drugs, and anti-asthma drugs (other than short acting inhaled beta-agonists supplied as&#xD;
        rescue medication, oral contraceptives, non-steroidal anti-inflammatory drugs, stable doses&#xD;
        of antihistamines, and paracetamol) for 1 week prior to screening and throughout the course&#xD;
        of the study. Anti-histamines should be withheld 4 days prior to AMP challenge; subjects&#xD;
        must also be able to abstain from short acting inhaled beta-agonists, for 8 hours prior to&#xD;
        spirometry. - Subjects undergoing de-sensitization therapy - Current smokers who smoke &gt; 20&#xD;
        cigarettes per week or the equivalent unit dose of other tobacco products or e-cigarettes,&#xD;
        or smokers with a smoking history of &gt;=10 pack years. - History of regular alcohol&#xD;
        consumption exceeding 21 units per week for men and 14 units per week for females (1 unit&#xD;
        =5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of spirits)&#xD;
        within 6 months of screening. - All subjects who are currently or in the last month have&#xD;
        worked night-shifts are excluded from the study - Exposure to more than four new chemical&#xD;
        entities within 12 months prior to the first dosing day or received an investigational&#xD;
        product within 30 days of study start, or 5 half-lives of study drug if that is longer. - A&#xD;
        subject has any clinically significant, uncontrolled condition or disease state that, in&#xD;
        the opinion of the investigator, would put the safety of the subject at risk through study&#xD;
        participation or would confound the interpretation of the study results if the&#xD;
        condition/disease exacerbated during the study. (e.g. stroke or myocardial infarction&#xD;
        within 3 months, uncontrolled hypertension, congestive heart failure, uncontrolled diabetes&#xD;
        mellitus.) - Evidence of cancer or history of cancer in the past 5 years other than&#xD;
        adequately treated basal or squamous cell carcinoma of the skin or adequately treated in&#xD;
        situ carcinoma of the cervix. - Pregnant females as determined by positive urine HCG test&#xD;
        at screening or by positive urine HCG test prior to dosing and lactating females. -&#xD;
        Subjects with active or chronic infections including hepatitis B or C, human&#xD;
        immunodeficiency virus. A positive serology at screening. - Allergies: History of severe&#xD;
        milk protein allergy Drug Allergy defined as any adverse reaction including immediate or&#xD;
        delayed hypersensitivity to intranasal, inhaled, or systemic corticosteroid therapy. Known&#xD;
        or suspected sensitivity to the constituents of FF, FP or BUD (i.e., lactose or magnesium&#xD;
        stearate etc.) Historical Allergy defined as history of drug or other allergy that, in the&#xD;
        opinion of the investigator or GSK Medical Monitor, contraindicates their participation. -&#xD;
        Significant abnormality in the 12-lead electrocardiogram (ECG) performed at screening. The&#xD;
        mean of the three individual ECGs will be taken. Mean QT interval corrected for heart rate&#xD;
        (QTc) &gt;450 millisecond (msec) for males or QTc&gt;470 msec for female subjects and &gt;480 in&#xD;
        subjects with bundle branch block. The QTc is the QT interval corrected for heart rate&#xD;
        according to Fridericia's formula (QTcF).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>14050</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Harrow</city>
        <state>Middlesex</state>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9QZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <results_first_submitted>December 19, 2019</results_first_submitted>
  <results_first_submitted_qc>March 26, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 30, 2020</results_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dose-response</keyword>
  <keyword>AMP challenge</keyword>
  <keyword>cortisol suppression</keyword>
  <keyword>dose escalation</keyword>
  <keyword>therapeutic index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluticasone</mesh_term>
    <mesh_term>Xhance</mesh_term>
    <mesh_term>Budesonide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD is available via the Clinical Study Data Request site (click on the link provided below)</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>https://clinicalstudydatarequest.com/Posting.aspx?ID=20386</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT02991859/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT02991859/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 56 participants were enrolled across 1 center in Germany and 2 centers in the United Kingdom.</recruitment_details>
      <pre_assignment_details>A total of 165 participants were screened of which 109 failed screening and 56 participants were enrolled in study. Of the 56 participants enrolled,only 54 were randomized and received at least one dose of study medication. Only 7 participants were withdrawn from the study, 2 participants who were not withdrawn, entered Period 2 esc Phase 1.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Arm AB - FF Followed by FP</title>
          <description>Participants received evening (PM) dose of 1 puff of Fluticasone Furoate (FF) 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="P2">
          <title>Arm AC - FF Followed by BUD</title>
          <description>Participants received PM dose of 1 puff of FF 25mcg (TDD=25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD=100 mcg) in second phase; PM dose of 1 puff of FF 200mcg (TDD=200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD =800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="P3">
          <title>Arm AD - FF Followed by ELLIPTA Placebo</title>
          <description>Participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="P4">
          <title>Arm BA - FP Followed by FF</title>
          <description>Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="P5">
          <title>Arm BC - FP Followed by BUD</title>
          <description>Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="P6">
          <title>Arm BE - FP Followed by DISKUS Placebo</title>
          <description>Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="P7">
          <title>Arm CA - BUD Followed by FF</title>
          <description>Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="P8">
          <title>Arm CB - BUD Followed by FP</title>
          <description>Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD =500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="P9">
          <title>Arm CE - BUD Followed by DISKUS Placebo</title>
          <description>Participants received PM dose of 1 puff of BUD as 100 mcg in first phase followed by BUD 200 mcg 1 puff AM and PM (TDD=400 mcg), in third phase BUD 400 mcg 1 puff AM and PM (TDD=800 mcg) followed by BUD 400 mcg 2 puffs AM and PM(TDD=1600mcg) in fourth phase followed by BUD 400 mcg 4puffs AM and PM (TDD=3200mcg) in TP1. In TP 2 participants received DISKUS placebo 1 puff PM in first phase followed by DISKUS placebo 1 puff AM and PM in second phase followed by DISKUS placebo 1 puff AM and PM in third phase followed by DISKUS placebo 1 puff AM and PM in fourth phase followed by DISKUS placebo 2 puffs AM and PM in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="P10">
          <title>Arm DA - ELLIPTA Placebo Followed by FF</title>
          <description>Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="P11">
          <title>EB - DISKUS Placebo Followed by FP</title>
          <description>Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each of DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="P12">
          <title>Arm DC - ELLIPTA Placebo Followed by BUD</title>
          <description>Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="P13">
          <title>Fluticasone Furoate (FF)</title>
          <description>Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.</description>
        </group>
        <group group_id="P14">
          <title>Fluticasone Propionate (FP)</title>
          <description>Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase.</description>
        </group>
        <group group_id="P15">
          <title>Budesonide (BUD)</title>
          <description>Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.</description>
        </group>
        <group group_id="P16">
          <title>ELLIPTA</title>
          <description>Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase.</description>
        </group>
        <group group_id="P17">
          <title>DISKUS</title>
          <description>Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1,Escalation Phase 1,Upto Day 7</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="7"/>
                <participants group_id="P14" count="7"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="3"/>
                <participants group_id="P17" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="7"/>
                <participants group_id="P14" count="7"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="3"/>
                <participants group_id="P17" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 1,Escalation Phase2,Upto Day 14</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="7"/>
                <participants group_id="P14" count="7"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="3"/>
                <participants group_id="P17" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="7"/>
                <participants group_id="P14" count="7"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="3"/>
                <participants group_id="P17" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period1, Escalation Phase3, Upto Day21</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="7"/>
                <participants group_id="P14" count="7"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="3"/>
                <participants group_id="P17" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="6"/>
                <participants group_id="P14" count="6"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="3"/>
                <participants group_id="P17" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period1, Escalation Phase4, Upto Day28</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="2">1 Par completed Phase 3 did not enter Phase 4</participants>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="6"/>
                <participants group_id="P14" count="6"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="3"/>
                <participants group_id="P17" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="6"/>
                <participants group_id="P14" count="6"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="3"/>
                <participants group_id="P17" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period1, Escalation Phase5, Upto Day35</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="1">1 participant did not enter Esc Phase 5, and was not withdrawn</participants>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="6"/>
                <participants group_id="P14" count="6"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="3"/>
                <participants group_id="P17" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="6"/>
                <participants group_id="P14" count="6"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="3"/>
                <participants group_id="P17" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Wash Out, Up to Day 77</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="0">Participants did not enter washout and Period 2</participants>
                <participants group_id="P14" count="0">Participants did not enter washout and Period 2</participants>
                <participants group_id="P15" count="0">Participants did not enter washout and Period 2</participants>
                <participants group_id="P16" count="0">Participants did not enter washout and Period 2</participants>
                <participants group_id="P17" count="0">Participants did not enter washout and Period 2</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </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="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period2, Escalation Phase1, Upto Day 84</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2">1 Par directly entered into Period 2, Esc 1</participants>
                <participants group_id="P11" count="2">1 Par cont in P2 Esc 1 insteadP1 Esc 5, was not withdrawn</participants>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period2, Escalation Phase2, Upto Day 91</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period2, Escalation Phase3, Upto Day 98</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period2, Escalation Phase4, Upto Day 105</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period2,Escalation Phase5,Upto Day 112</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="2"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arm AB - FF Followed by FP</title>
          <description>Participants received evening (PM) dose of 1 puff of Fluticasone Furoate (FF) 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="B2">
          <title>AC - FF Followed by BUD</title>
          <description>Participants will receive PM dose of 1 puff of FF 25mcg (TDD=25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD=100 mcg) in second phase; PM dose of 1 puff of FF 200mcg (TDD=200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD =800 mcg) in fifth phase. In TP 2, participants will receive PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase. Washout period will be of 25-42 days</description>
        </group>
        <group group_id="B3">
          <title>Arm AD - FF Followed by ELLIPTA Placebo</title>
          <description>Participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="B4">
          <title>Arm BA - FP Followed by FF</title>
          <description>Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="B5">
          <title>Arm BC - FP Followed by BUD</title>
          <description>Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="B6">
          <title>Arm BE - FP Followed by DISKUS Placebo</title>
          <description>Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="B7">
          <title>Arm CA - BUD Followed by FF</title>
          <description>Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="B8">
          <title>Arm CB - BUD Followed by FP</title>
          <description>Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD =500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="B9">
          <title>Arm CE - BUD Followed by DISKUS Placebo</title>
          <description>Participants received PM dose of 1 puff of BUD as 100 mcg in first phase followed by BUD 200 mcg 1 puff AM and PM (TDD=400 mcg), in third phase BUD 400 mcg 1 puff AM and PM (TDD=800 mcg) followed by BUD 400 mcg 2 puffs AM and PM(TDD=1600mcg) in fourth phase followed by BUD 400 mcg 4puffs AM and PM (TDD=3200mcg) in TP1. In TP 2 participants received DISKUS placebo 1 puff PM in first phase followed by DISKUS placebo 1 puff AM and PM in second phase followed by DISKUS placebo 1 puff AM and PM in third phase followed by DISKUS placebo 1 puff AM and PM in fourth phase followed by DISKUS placebo 2 puffs AM and PM in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="B10">
          <title>Arm DA - ELLIPTA Placebo Followed by FF</title>
          <description>Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="B11">
          <title>EB - DISKUS Placebo Followed by FP</title>
          <description>Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each of DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="B12">
          <title>Arm DC - ELLIPTA Placebo Followed by BUD</title>
          <description>Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.</description>
        </group>
        <group group_id="B13">
          <title>Fluticasone Furoate (FF)</title>
          <description>Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.</description>
        </group>
        <group group_id="B14">
          <title>Fluticasone Propionate (FP)</title>
          <description>Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase.</description>
        </group>
        <group group_id="B15">
          <title>Budesonide (BUD)</title>
          <description>Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.</description>
        </group>
        <group group_id="B16">
          <title>ELLIPTA</title>
          <description>Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase.</description>
        </group>
        <group group_id="B17">
          <title>DISKUS</title>
          <description>Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase.</description>
        </group>
        <group group_id="B18">
          <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="2"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="2"/>
            <count group_id="B4" value="2"/>
            <count group_id="B5" value="3"/>
            <count group_id="B6" value="3"/>
            <count group_id="B7" value="2"/>
            <count group_id="B8" value="2"/>
            <count group_id="B9" value="2"/>
            <count group_id="B10" value="3"/>
            <count group_id="B11" value="2"/>
            <count group_id="B12" value="2"/>
            <count group_id="B13" value="7"/>
            <count group_id="B14" value="7"/>
            <count group_id="B15" value="6"/>
            <count group_id="B16" value="3"/>
            <count group_id="B17" value="3"/>
            <count group_id="B18" value="54"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;=18 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="1"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="1"/>
                    <measurement group_id="B18" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 to 64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="2"/>
                    <measurement group_id="B13" value="7"/>
                    <measurement group_id="B14" value="7"/>
                    <measurement group_id="B15" value="5"/>
                    <measurement group_id="B16" value="3"/>
                    <measurement group_id="B17" value="2"/>
                    <measurement group_id="B18" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>65 to 84 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="1"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="2"/>
                    <measurement group_id="B14" value="3"/>
                    <measurement group_id="B15" value="1"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="2"/>
                    <measurement group_id="B13" value="5"/>
                    <measurement group_id="B14" value="4"/>
                    <measurement group_id="B15" value="5"/>
                    <measurement group_id="B16" value="3"/>
                    <measurement group_id="B17" value="3"/>
                    <measurement group_id="B18" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>ASIAN - CENTRAL/SOUTH ASIAN HERITAGE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="1"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="1"/>
                    <measurement group_id="B18" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASIAN - EAST ASIAN HERITAGE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AFRICAN AMERICAN/AFRICAN HERITAGE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="2"/>
                    <measurement group_id="B14" value="1"/>
                    <measurement group_id="B15" value="1"/>
                    <measurement group_id="B16" value="1"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WHITE - ARABIC/NORTH AFRICAN HERITAGE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MULTIPLE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="3"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="2"/>
                    <measurement group_id="B13" value="5"/>
                    <measurement group_id="B14" value="6"/>
                    <measurement group_id="B15" value="4"/>
                    <measurement group_id="B16" value="2"/>
                    <measurement group_id="B17" value="2"/>
                    <measurement group_id="B18" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis</title>
        <description>The percentage fall in FEV1 was calculated using highest FEV1 (post saline) minus highest FEV1 (post AMP) divided by highest FEV1 (post saline)*100 where highest FEV1 (post saline) is the highest value of two FEV1 measurements at 60 and 180 seconds after the saline control, highest FEV1 (post AMP) is the highest value of the two FEV1 measurements at 60 and 180 seconds after the dose of AMP. Results are presented treatment wise. The analysis method was a 3 parameter Emax model with log 2 transformed AMP PC20 as the outcome variable, assuming common Emax across FF, FP and BUD, and with an unstructured variance-covariance matrix. Mean and 95% Confidence Interval (CI) presented are predicted estimate.</description>
        <time_frame>12 hours post last dose on Day 7</time_frame>
        <population>Pharmacodymanic (PD) population. Participants who were randomized and received at least one dose of trial medication and also have at least one post dose PD measurement. Only those participants with data available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>FF 25 mcg</title>
            <description>Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FF 100 mcg</title>
            <description>Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>FF 200 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>FF 400 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O5">
            <title>FF 800 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O6">
            <title>FP 50 mcg</title>
            <description>Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O7">
            <title>FP 200 mcg</title>
            <description>Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O8">
            <title>FP 500 mcg</title>
            <description>Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O9">
            <title>FP 1000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O10">
            <title>FP 2000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O11">
            <title>BUD 100 mcg</title>
            <description>Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O12">
            <title>BUD 400 mcg</title>
            <description>Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O13">
            <title>BUD 800 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O14">
            <title>BUD 1600 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O15">
            <title>BUD 3200 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis</title>
          <description>The percentage fall in FEV1 was calculated using highest FEV1 (post saline) minus highest FEV1 (post AMP) divided by highest FEV1 (post saline)*100 where highest FEV1 (post saline) is the highest value of two FEV1 measurements at 60 and 180 seconds after the saline control, highest FEV1 (post AMP) is the highest value of the two FEV1 measurements at 60 and 180 seconds after the dose of AMP. Results are presented treatment wise. The analysis method was a 3 parameter Emax model with log 2 transformed AMP PC20 as the outcome variable, assuming common Emax across FF, FP and BUD, and with an unstructured variance-covariance matrix. Mean and 95% Confidence Interval (CI) presented are predicted estimate.</description>
          <population>Pharmacodymanic (PD) population. Participants who were randomized and received at least one dose of trial medication and also have at least one post dose PD measurement. Only those participants with data available at the specified time points were analyzed.</population>
          <units>Milligrams per milliliter</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="17"/>
                <count group_id="O6" value="20"/>
                <count group_id="O7" value="20"/>
                <count group_id="O8" value="18"/>
                <count group_id="O9" value="16"/>
                <count group_id="O10" value="17"/>
                <count group_id="O11" value="18"/>
                <count group_id="O12" value="18"/>
                <count group_id="O13" value="18"/>
                <count group_id="O14" value="18"/>
                <count group_id="O15" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.45" lower_limit="19.10" upper_limit="58.60"/>
                    <measurement group_id="O2" value="81.45" lower_limit="44.65" upper_limit="148.58"/>
                    <measurement group_id="O3" value="115.69" lower_limit="66.82" upper_limit="200.31"/>
                    <measurement group_id="O4" value="145.97" lower_limit="85.02" upper_limit="250.59"/>
                    <measurement group_id="O5" value="167.26" lower_limit="95.36" upper_limit="293.37"/>
                    <measurement group_id="O6" value="15.19" lower_limit="10.80" upper_limit="21.36"/>
                    <measurement group_id="O7" value="20.47" lower_limit="13.94" upper_limit="30.07"/>
                    <measurement group_id="O8" value="31.39" lower_limit="18.88" upper_limit="52.19"/>
                    <measurement group_id="O9" value="48.67" lower_limit="27.30" upper_limit="86.78"/>
                    <measurement group_id="O10" value="76.35" lower_limit="43.21" upper_limit="134.91"/>
                    <measurement group_id="O11" value="16.00" lower_limit="11.41" upper_limit="22.44"/>
                    <measurement group_id="O12" value="23.91" lower_limit="15.08" upper_limit="37.90"/>
                    <measurement group_id="O13" value="34.62" lower_limit="19.28" upper_limit="62.16"/>
                    <measurement group_id="O14" value="54.33" lower_limit="28.40" upper_limit="103.93"/>
                    <measurement group_id="O15" value="84.17" lower_limit="45.48" upper_limit="155.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>3 parameter Emax model</param_type>
            <param_value>13.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.39</ci_lower_limit>
            <ci_upper_limit>19.39</ci_upper_limit>
            <estimate_desc>FF E0 (Response of Placebo participants)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>3 parameter Emax model</param_type>
            <param_value>14.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.21</ci_lower_limit>
            <ci_upper_limit>25.40</ci_upper_limit>
            <estimate_desc>Emax-Maximum Dose response</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>3 parameter Emax model</param_type>
            <param_value>48.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>18.21</ci_lower_limit>
            <ci_upper_limit>129.32</ci_upper_limit>
            <estimate_desc>ED50-Dose at which 50% of the maximum dose response reached (mcg)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
              <group_id>O9</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>3 parameter Emax model</param_type>
            <param_value>13.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.39</ci_lower_limit>
            <ci_upper_limit>19.39</ci_upper_limit>
            <estimate_desc>FP E0-Response of Placebo participants</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
              <group_id>O9</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>3 parameter Emax model</param_type>
            <param_value>14.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.21</ci_lower_limit>
            <ci_upper_limit>25.40</ci_upper_limit>
            <estimate_desc>FP Emax-Maximum Dose response</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
              <group_id>O9</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>3 parameter Emax model</param_type>
            <param_value>1081.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>448.00</ci_lower_limit>
            <ci_upper_limit>2609.66</ci_upper_limit>
            <estimate_desc>FP ED50-Dose at which 50% of the maximum dose response reached (mcg)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
              <group_id>O13</group_id>
              <group_id>O14</group_id>
              <group_id>O15</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>3 parameter Emax model</param_type>
            <param_value>13.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.39</ci_lower_limit>
            <ci_upper_limit>19.39</ci_upper_limit>
            <estimate_desc>BUD E0-Response of Placebo participants</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
              <group_id>O13</group_id>
              <group_id>O14</group_id>
              <group_id>O15</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>3 parameter Emax model</param_type>
            <param_value>14.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.21</ci_lower_limit>
            <ci_upper_limit>25.40</ci_upper_limit>
            <estimate_desc>BUD Emax-Maximum Dose response</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
              <group_id>O13</group_id>
              <group_id>O14</group_id>
              <group_id>O15</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>3 parameter Emax model</param_type>
            <param_value>1467.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>546.51</ci_lower_limit>
            <ci_upper_limit>3939.84</ci_upper_limit>
            <estimate_desc>BUD ED50-Dose at which 50% of the maximum dose response reached (mcg)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cortisol Suppression 0-24 Hours Weighted Mean-Dose Response Analysis</title>
        <description>Blood samples for measurement of plasma cortisol were collected at given time point. The weighted means were derived by calculating the area under the curve (AUC) over the 0-24-hour period using the trapezoidal rule, and then dividing it by the actual time interval. Results are presented treatment wise. Mean and 95% CI presented are predicted estimate. The analysis method was an inhibitory exponential power-law model with log e transformed cortisol as the outcome variable, assuming 100% inhibition at highest doses.</description>
        <time_frame>Pre-dose PM dose on Day 6 to pre-dose PM dose Day 7</time_frame>
        <population>PD population. Only those participants with data available for each dose escalation phase were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>FF 25 mcg</title>
            <description>Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FF 100 mcg</title>
            <description>Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>FF 200 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>FF 400 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O5">
            <title>FF 800 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O6">
            <title>FP 50 mcg</title>
            <description>Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O7">
            <title>FP 200 mcg</title>
            <description>Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O8">
            <title>FP 500 mcg</title>
            <description>Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O9">
            <title>FP 1000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O10">
            <title>FP 2000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O11">
            <title>BUD 100 mcg</title>
            <description>Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O12">
            <title>BUD 400 mcg</title>
            <description>Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O13">
            <title>BUD 800 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O14">
            <title>BUD 1600 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O15">
            <title>BUD 3200 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Cortisol Suppression 0-24 Hours Weighted Mean-Dose Response Analysis</title>
          <description>Blood samples for measurement of plasma cortisol were collected at given time point. The weighted means were derived by calculating the area under the curve (AUC) over the 0-24-hour period using the trapezoidal rule, and then dividing it by the actual time interval. Results are presented treatment wise. Mean and 95% CI presented are predicted estimate. The analysis method was an inhibitory exponential power-law model with log e transformed cortisol as the outcome variable, assuming 100% inhibition at highest doses.</description>
          <population>PD population. Only those participants with data available for each dose escalation phase were analyzed.</population>
          <units>nanomoles per liter</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="18"/>
                <count group_id="O6" value="20"/>
                <count group_id="O7" value="19"/>
                <count group_id="O8" value="18"/>
                <count group_id="O9" value="16"/>
                <count group_id="O10" value="16"/>
                <count group_id="O11" value="16"/>
                <count group_id="O12" value="16"/>
                <count group_id="O13" value="18"/>
                <count group_id="O14" value="18"/>
                <count group_id="O15" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="172.73" lower_limit="159.88" upper_limit="186.62"/>
                    <measurement group_id="O2" value="163.03" lower_limit="151.01" upper_limit="176.02"/>
                    <measurement group_id="O3" value="150.95" lower_limit="139.48" upper_limit="163.37"/>
                    <measurement group_id="O4" value="129.40" lower_limit="117.82" upper_limit="142.12"/>
                    <measurement group_id="O5" value="95.09" lower_limit="82.26" upper_limit="109.93"/>
                    <measurement group_id="O6" value="173.04" lower_limit="160.15" upper_limit="186.97"/>
                    <measurement group_id="O7" value="164.22" lower_limit="152.11" upper_limit="177.29"/>
                    <measurement group_id="O8" value="147.89" lower_limit="136.59" upper_limit="160.13"/>
                    <measurement group_id="O9" value="124.21" lower_limit="112.88" upper_limit="136.68"/>
                    <measurement group_id="O10" value="87.62" lower_limit="75.37" upper_limit="101.85"/>
                    <measurement group_id="O11" value="169.87" lower_limit="157.23" upper_limit="183.52"/>
                    <measurement group_id="O12" value="152.50" lower_limit="141.26" upper_limit="164.63"/>
                    <measurement group_id="O13" value="132.06" lower_limit="122.05" upper_limit="142.90"/>
                    <measurement group_id="O14" value="99.05" lower_limit="90.24" upper_limit="108.72"/>
                    <measurement group_id="O15" value="55.71" lower_limit="48.26" upper_limit="64.31"/>
                  </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>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Exponential power-law model</param_type>
            <param_value>176.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>162.87</ci_lower_limit>
            <ci_upper_limit>190.38</ci_upper_limit>
            <estimate_desc>FF E0-Response of Placebo participants</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>exponential power-law model</param_type>
            <param_value>899.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>698.36</ci_lower_limit>
            <ci_upper_limit>1101.62</ci_upper_limit>
            <estimate_desc>FF ED50 Dose at which 50% of the maximum dose response reached</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
              <group_id>O9</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>exponential power-law model</param_type>
            <param_value>176.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>162.87</ci_lower_limit>
            <ci_upper_limit>190.38</ci_upper_limit>
            <estimate_desc>FP E0-Response of Placebo participants</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
              <group_id>O9</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>exponential power-law model</param_type>
            <param_value>1986.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1574.70</ci_lower_limit>
            <ci_upper_limit>2397.39</ci_upper_limit>
            <estimate_desc>FP ED50 - Dose at which 50% of the maximum dose response reached (mcg)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
              <group_id>O13</group_id>
              <group_id>O14</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>exponential power-law model</param_type>
            <param_value>176.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>162.87</ci_lower_limit>
            <ci_upper_limit>190.38</ci_upper_limit>
            <estimate_desc>BUD E0 - Response of Placebo participants</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
              <group_id>O13</group_id>
              <group_id>O14</group_id>
              <group_id>O15</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>exponential power-law model</param_type>
            <param_value>1927.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1698.47</ci_lower_limit>
            <ci_upper_limit>2156.37</ci_upper_limit>
            <estimate_desc>BUD ED50 - Dose at which 50% of the maximum dose response reached (mcg)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Theraputic Index of FF</title>
        <description>Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by Dose at which 80% of the maximum effect is reached (ED80) for AMP PC20 for FF 25 mcg, FF 100 mcg, FF 200 mcg, FF 400 mcg, FF 800 mcg. Theraputic index has been presented. Only those participants with data available at the specified time points were analyzed. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.</description>
        <time_frame>12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7</time_frame>
        <population>PD population. Only those participants with data available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluticasone Propionate (FP)</title>
            <description>Participants received FF ELLIPTA 25 mcg, 100 mcg, 200 mcg, 400 mcg, 800 mcg for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Theraputic Index of FF</title>
          <description>Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by Dose at which 80% of the maximum effect is reached (ED80) for AMP PC20 for FF 25 mcg, FF 100 mcg, FF 200 mcg, FF 400 mcg, FF 800 mcg. Theraputic index has been presented. Only those participants with data available at the specified time points were analyzed. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.</description>
          <population>PD population. Only those participants with data available at the specified time points were analyzed.</population>
          <units>Ratio</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Emax Model</param_type>
            <param_value>289.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>224.82</ci_lower_limit>
            <ci_upper_limit>354.64</ci_upper_limit>
            <estimate_desc>ED20 Cortisol Suppression 0-24 Hours Weighted Mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Emax Model</param_type>
            <param_value>194.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>72.82</ci_lower_limit>
            <ci_upper_limit>517.28</ci_upper_limit>
            <estimate_desc>ED80 for AMP PC20</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Theraputic Index of FP</title>
        <description>Therapeutic Index was calculated by Dose at which 20% of the maximum effect is reached (ED20) for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by ED80 for AMP PC20 for FP 50 mcg, FP 200 mcg, FP 500 mcg, FP 1000 mcg, FP 2000 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.</description>
        <time_frame>12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7</time_frame>
        <population>PD population. Only those participants with data available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluticasone Propionate (FP)</title>
            <description>Participants received FP ELLIPTA 50 mg, 200 mcg, 500 mcg, 1000 mcg, 2000 mcg for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Theraputic Index of FP</title>
          <description>Therapeutic Index was calculated by Dose at which 20% of the maximum effect is reached (ED20) for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by ED80 for AMP PC20 for FP 50 mcg, FP 200 mcg, FP 500 mcg, FP 1000 mcg, FP 2000 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.</description>
          <population>PD population. Only those participants with data available at the specified time points were analyzed.</population>
          <units>Ratio</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Emax Model</param_type>
            <param_value>639.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>506.94</ci_lower_limit>
            <ci_upper_limit>771.79</ci_upper_limit>
            <estimate_desc>ED20 for Cortisol Suppression 0-24 Hours Weighted Mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Emax Model</param_type>
            <param_value>4325.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1792.02</ci_lower_limit>
            <ci_upper_limit>10438.64</ci_upper_limit>
            <estimate_desc>ED80 for AMP PC20</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Theraputic Index of BUD</title>
        <description>Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by ED80 for AMP PC20 for BUD 100 mcg, BUD 400 mcg, BUD 800 mcg, BUD 1600 mcg, BUD 3200 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.</description>
        <time_frame>12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7</time_frame>
        <population>PD population. Only those participants with data available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Budesonide (BUD)</title>
            <description>Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Theraputic Index of BUD</title>
          <description>Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by ED80 for AMP PC20 for BUD 100 mcg, BUD 400 mcg, BUD 800 mcg, BUD 1600 mcg, BUD 3200 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.</description>
          <population>PD population. Only those participants with data available at the specified time points were analyzed.</population>
          <units>Ratio</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Emax Model</param_type>
            <param_value>620.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>546.79</ci_lower_limit>
            <ci_upper_limit>694.20</ci_upper_limit>
            <estimate_desc>ED20 for Cortisol Suppression 0-24 Hours Weighted Mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Emax Model</param_type>
            <param_value>5869.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2186.03</ci_lower_limit>
            <ci_upper_limit>15759.35</ci_upper_limit>
            <estimate_desc>ED80 for AMP PC20</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)</title>
        <description>An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that at any dose results in death, Is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Results are presented treatment wise.</description>
        <time_frame>Up to Week 18</time_frame>
        <population>All Subjects Population was consisted of all participants who were randomized and who received at least one dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FF 25 mcg</title>
            <description>Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>FF 100 mcg</title>
            <description>Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>FF 200 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O5">
            <title>FF 400 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O6">
            <title>FF 800 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O7">
            <title>FP 50 mcg</title>
            <description>Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O8">
            <title>FP 200 mcg</title>
            <description>Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O9">
            <title>FP 500 mcg</title>
            <description>Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O10">
            <title>FP 1000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O11">
            <title>FP 2000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O12">
            <title>BUD 100 mcg</title>
            <description>Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O13">
            <title>BUD 400 mcg</title>
            <description>Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O14">
            <title>BUD 800 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O15">
            <title>BUD 1600 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O16">
            <title>BUD 3200 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)</title>
          <description>An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that at any dose results in death, Is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Results are presented treatment wise.</description>
          <population>All Subjects Population was consisted of all participants who were randomized and who received at least one dose of trial medication.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="18"/>
                <count group_id="O6" value="18"/>
                <count group_id="O7" value="21"/>
                <count group_id="O8" value="20"/>
                <count group_id="O9" value="20"/>
                <count group_id="O10" value="18"/>
                <count group_id="O11" value="17"/>
                <count group_id="O12" value="18"/>
                <count group_id="O13" value="18"/>
                <count group_id="O14" value="18"/>
                <count group_id="O15" value="18"/>
                <count group_id="O16" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="7"/>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="4"/>
                    <measurement group_id="O10" value="8"/>
                    <measurement group_id="O11" value="6"/>
                    <measurement group_id="O12" value="6"/>
                    <measurement group_id="O13" value="8"/>
                    <measurement group_id="O14" value="5"/>
                    <measurement group_id="O15" value="6"/>
                    <measurement group_id="O16" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</description>
        <time_frame>Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in period 1</time_frame>
        <population>All subjects Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</description>
          <population>All subjects Population.</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2, PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="522.5" spread="25.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3, PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="517.5" spread="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4, PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="514.2" spread="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5,PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="521.7" spread="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6, PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="522.5" spread="29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="539.2" spread="32.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8, PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="530.8" spread="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9, AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="576.0" spread="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9, PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="531.3" spread="27.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10, AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="572.0" spread="34.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10, PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="535.0" spread="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11, AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="578.0" spread="35.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11, PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="533.8" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12, AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="578.0" spread="37.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12 PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="527.5" spread="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13, AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="580.0" spread="37.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13, PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="540.8" spread="25.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="572.0" spread="34.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="543.3" spread="26.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15, PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="530.8" spread="26.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16, AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="588.0" spread="36.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16,PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="528.3" spread="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17, AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="586.0" spread="31.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17,PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="521.7" spread="32.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18, AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="586.0" spread="35.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18,PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="540.0" spread="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19, AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="568.0" spread="38.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19,PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="535.8" spread="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20, AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="596.0" spread="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20,PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="544.2" spread="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21, AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="580.0" spread="31.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21,PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="534.2" spread="32.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22,PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="544.5" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23, AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="577.5" spread="37.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23,PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="530.0" spread="27.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24, AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="567.5" spread="39.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24,PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="526.4" spread="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25, AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="585.0" spread="39.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25,PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="530.9" spread="29.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26, AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="582.5" spread="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26,PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="518.2" spread="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27, AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="587.5" spread="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27,PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="539.1" spread="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="587.5" spread="43.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28,PM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="547.0" spread="30.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29,PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="547.3" spread="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30, AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="567.5" spread="38.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30,PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="527.3" spread="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31, AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="562.5" spread="33.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31,PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="537.3" spread="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32, AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="582.5" spread="40.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32,PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="537.3" spread="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33, AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="597.5" spread="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33,PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="528.2" spread="30.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34, AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="580.0" spread="39.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34,PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="531.4" spread="31.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35, AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="565.0" spread="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35,PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="501.8" spread="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability of Placebo in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.</description>
        <time_frame>Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in Period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability of Placebo in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2, PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="422.5" spread="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3, PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="415.0" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4, PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="398.8" spread="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5,PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="407.5" spread="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6, PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="411.3" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="410.0" spread="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8, PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="415.0" spread="36.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9, AM, n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="430.0" spread="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9, PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="411.3" spread="45.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10, AM, n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="425.0" spread="65.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10, PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="403.8" spread="37.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11, AM, n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="410.0" spread="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11, PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="395.0" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12, AM, n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="400.0" spread="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12, PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="398.8" spread="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13, AM, n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="415.0" spread="95.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13, PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="425.0" spread="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, AM, n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="425.0" spread="65.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, PM, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="420.0" spread="40.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15, PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="416.3" spread="37.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16, AM, n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="405.0" spread="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16,PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="405.0" spread="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17, AM, n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="390.0" spread="70.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17,PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="405.0" spread="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18, AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="450.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18,PM,n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="423.3" spread="34.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19, AM, n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="415.0" spread="65.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19,PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="402.5" spread="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20, AM, n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="402.5" spread="57.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20,PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="398.8" spread="36.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21, AM, n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="400.0" spread="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21,PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="395.0" spread="38.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22,PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="397.5" spread="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23, AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="480.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23,PM, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="415.0" spread="39.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24, AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="460.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24,PM, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="423.3" spread="38.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25, AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="460.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25,PM, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="416.7" spread="33.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26, AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="450.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26,PM, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="418.3" spread="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27, AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="460.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27,PM, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="433.3" spread="49.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="460.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28,PM, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="430.0" spread="49.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29,PM, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="380.0" spread="75.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30, AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="460.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30,PM, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="388.3" spread="78.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31, AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="480.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31,PM, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="390.0" spread="85.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32, AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32,PM, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="370.0" spread="73.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33, AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="470.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33,PM, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="370.0" spread="70.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34, AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="460.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34,PM, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="390.0" spread="83.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35, AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="480.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35,PM, n=2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="345.0" spread="105.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 2,3,4,5,6,7 PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>FF 25 mcg</title>
            <description>Participants received FF ELLIPTA 25 mcg 1 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2, PM, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="479.6" spread="30.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3, PM, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="475.7" spread="32.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4, PM, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="473.0" spread="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5,PM, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="476.1" spread="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6, PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="503.1" spread="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="502.3" spread="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 2,3,4,5,6,7 PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>FF 25 mcg</title>
            <description>Participants received FF ELLIPTA 25 mcg 1 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2, PM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="572.0" spread="48.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3, PM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="570.0" spread="54.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4, PM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="568.0" spread="55.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5,PM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="573.0" spread="54.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6, PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="550.8" spread="52.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="560.0" spread="45.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 8,9,10,11,12,13,14 PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>FF 100 mcg</title>
            <description>Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8, PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="497.3" spread="24.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9, PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.4" spread="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10, PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="491.2" spread="31.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11, PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="507.5" spread="30.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12, PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.2" spread="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13, PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="515.4" spread="29.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="505.8" spread="28.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 8,9,10,11,12,13,14 PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>FF 100 mcg</title>
            <description>Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8, PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="540.0" spread="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9, PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="567.5" spread="42.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10, PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="556.7" spread="43.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11, PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="561.7" spread="44.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12, PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="573.3" spread="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13, PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="563.3" spread="53.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="555.8" spread="46.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 15,16,17,18,19,20,21 PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>FF 200 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15,PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.8" spread="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16,PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.0" spread="28.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17,PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="506.2" spread="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18,PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="514.2" spread="31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19,PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="505.4" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20,PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="505.8" spread="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21,PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="485.0" spread="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 15,16,17,18,19,20 PM, Day 21 AM and PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>FF 200 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15,PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="575.0" spread="52.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16,PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="575.0" spread="48.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17,PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="564.2" spread="46.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18,PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="573.3" spread="56.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19,PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="556.7" spread="53.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20,PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="571.7" spread="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21,AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="670.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21,PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="560.0" spread="38.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Days 22,23,24,25,26,27,28 PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>FF 400 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 2 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="496.7" spread="30.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="481.0" spread="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="484.6" spread="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="488.3" spread="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="496.7" spread="28.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="508.8" spread="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="486.7" spread="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Days 22,23,24,25,26,27,28 PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>FF 400 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 2 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="556.7" spread="46.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="566.7" spread="47.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="571.7" spread="50.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="568.3" spread="52.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="565.0" spread="43.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="540.0" spread="43.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="541.7" spread="41.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Days 29,30,31,32,33,34,35 PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>FF 800 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 4 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 29 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="496.7" spread="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="487.1" spread="25.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="488.3" spread="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="481.3" spread="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="481.5" spread="24.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="487.5" spread="28.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="471.0" spread="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 29,30,31,32,33,34,35 PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>FF 400 mcg</title>
            <description>Participants received FF ELLIPTA 400 mcg 1 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 29 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="576.7" spread="44.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="560.0" spread="48.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="553.3" spread="45.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="565.0" spread="50.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="580.0" spread="48.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="568.3" spread="42.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="556.7" spread="44.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 2,3,4,5,6,7 PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>FP 50 mcg</title>
            <description>Participants received FP ELLIPTA 50 mcg 1 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2 PM, n=15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="529.3" spread="28.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 PM, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="533.6" spread="30.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 PM, n=15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="532.3" spread="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 PM, n=15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="524.0" spread="29.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6 PM, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="519.3" spread="26.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 PM, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="502.9" spread="35.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 2,3,4,5,6,7 AM and PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>FP 50 mcg</title>
            <description>Participants received FP ELLIPTA 50 mcg 1 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="600.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="490.0" spread="40.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="600.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="486.7" spread="42.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="590.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="491.7" spread="42.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="600.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="491.7" spread="44.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="600.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="490.0" spread="44.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="600.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="466.0" spread="48.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Days 8,9,1,0,11,12,13,14 AM and PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>FP 200 mcg</title>
            <description>Participants received FP DISKSU 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="540.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8 PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="532.7" spread="33.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.9" spread="38.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9 PM, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="517.9" spread="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="521.0" spread="39.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 PM, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="513.2" spread="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="476.4" spread="35.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11 PM, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="512.1" spread="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="506.8" spread="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12 PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="528.8" spread="34.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.0" spread="38.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13 PM, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="514.6" spread="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 AM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="496.2" spread="31.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day14 PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="522.7" spread="32.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 8,9,1,0,11,12,13,14 AM and PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>FP 200 mcg</title>
            <description>Participants received FP DISKSUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="610.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.0" spread="43.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9 AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="506.0" spread="39.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="488.3" spread="43.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="515.0" spread="44.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="490.0" spread="47.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11 AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="504.0" spread="36.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="485.0" spread="42.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12 AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="508.0" spread="41.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="493.3" spread="42.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13 AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.0" spread="40.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="495.0" spread="45.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="438.0" spread="46.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="495.8" spread="48.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).</description>
        <time_frame>Day 15 PM, Day 16,17,18,19,20,21,22,23,24,25,26,27,28 AM and PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>FP 500 mcg</title>
            <description>Participants received FP DISKSUS 250 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15 PM, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="527.5" spread="29.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 AM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="503.8" spread="31.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 PM, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="520.4" spread="29.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 AM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="510.0" spread="30.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 PM, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="508.6" spread="31.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18 AM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="497.5" spread="34.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18 PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="505.8" spread="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 AM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="505.8" spread="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="506.9" spread="29.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="518.2" spread="35.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 PM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="517.3" spread="30.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 AM, n=13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="501.9" spread="32.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="493.6" spread="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="520.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="540.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="530.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="550.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="530.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="540.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="510.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="520.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="550.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="530.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="580.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="530.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 15 PM, Day 16,17,18,19,20,21 AM and PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>FP 500 mcg</title>
            <description>Participants received FP DISKUS 250 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="486.7" spread="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 AM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="476.7" spread="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="503.3" spread="46.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 AM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="493.3" spread="44.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.0" spread="45.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18 AM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="476.7" spread="39.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="495.0" spread="42.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="454.0" spread="44.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.0" spread="45.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="524.0" spread="43.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="501.7" spread="50.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 AM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="490.0" spread="44.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="496.7" spread="48.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).</description>
        <time_frame>Day 22 PM, Day 23,24,25,26,27,28,29,30,31,32,33,34,35 AM and PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>FP 1000 mcg</title>
            <description>Participants received FP DISKSUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="523.2" spread="30.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="511.8" spread="36.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="516.4" spread="38.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="521.8" spread="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="520.9" spread="37.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="489.5" spread="35.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25 PM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="521.0" spread="42.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="502.7" spread="37.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="517.3" spread="35.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="493.6" spread="33.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="523.6" spread="37.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.0" spread="40.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28,PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="516.4" spread="33.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="530.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="520.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed..</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="530.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="510.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="530.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="520.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="550.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="530.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="540.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="510.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="520.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="540.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35 PM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="550.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>FP 1000 mcg</title>
            <description>Participants received FP DISKSUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="493.3" spread="42.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23 AM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="480.0" spread="43.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="506.7" spread="43.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24 AM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="481.7" spread="39.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="505.0" spread="45.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25 AM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="491.7" spread="43.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="510.0" spread="51.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26 AM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="485.0" spread="45.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="501.7" spread="49.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27 AM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="475.0" spread="42.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27 PM, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="490.0" spread="43.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28 AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="452.0" spread="47.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28,PM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="476.0" spread="56.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 29 PM, Day 30,31,32,33,34,35 AM and PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>FP 2000 mcg</title>
            <description>Participants received FP DISKSU 500 mcg 2 puffs AM and 2 puffs PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 29 PM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="520.5" spread="36.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="505.0" spread="39.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 PM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="520.0" spread="40.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="507.0" spread="37.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31 PM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="521.0" spread="41.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.0" spread="39.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32 PM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="524.0" spread="41.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="511.0" spread="40.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33 PM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="511.5" spread="43.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="519.0" spread="38.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34 PM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="517.0" spread="38.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35 AM, n=9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="514.4" spread="40.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35 PM, n=9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="543.9" spread="44.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 29 PM, Day 30,31,32,33,34,35 AM and PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>FP 2000 mcg</title>
            <description>Participants received FP DISKSU 500 mcg 2 puffs AM and 2 puffs PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 29 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="506.7" spread="45.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="493.3" spread="45.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="496.7" spread="46.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="486.7" spread="48.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="485.0" spread="41.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="488.3" spread="44.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="513.3" spread="52.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="495.0" spread="45.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="498.3" spread="44.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="481.7" spread="46.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="498.3" spread="47.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="483.3" spread="44.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="493.3" spread="46.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 2 to 6 AM and PM, Day 7 PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>BUD 100 mcg</title>
            <description>Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="600.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2 PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="512.9" spread="33.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="600.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="517.1" spread="31.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="625.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="524.2" spread="32.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="600.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="520.8" spread="32.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="600.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6 PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="523.3" spread="33.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="527.5" spread="33.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 2,3,4,5,6,7 PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>BUD 100 mcg</title>
            <description>Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2 PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="557.5" spread="28.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="547.5" spread="60.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="545.0" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="552.5" spread="46.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6 PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="577.5" spread="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 PM, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="603.3" spread="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 8 PM, Day 9 to 14 AM and PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>BUD 400 mcg</title>
            <description>Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8 PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="521.7" spread="31.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="473.0" spread="30.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9 PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="515.4" spread="34.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="470.0" spread="33.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 PM, n=12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="512.9" spread="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="466.7" spread="36.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="492.5" spread="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12 AM, n=9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="451.1" spread="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="509.5" spread="33.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13 AM, n=9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="457.8" spread="33.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="506.8" spread="33.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="480.5" spread="30.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="496.4" spread="32.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 8 PM, Day 9 to 14 AM and PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>BUD 400 mcg</title>
            <description>Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="560.0" spread="43.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="552.0" spread="40.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="560.0" spread="34.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="552.0" spread="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="556.0" spread="30.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="562.0" spread="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="574.0" spread="30.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="568.0" spread="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="578.0" spread="44.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="562.0" spread="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="588.0" spread="37.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="586.0" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="590.0" spread="44.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 15,16, 17, 18, 19, 20, 21 AM and PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>BUD 800 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15 AM, n=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="610.0" spread="NA">NA indicates standard error could not be calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="515.5" spread="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="494.5" spread="31.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="507.3" spread="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="484.1" spread="33.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="505.0" spread="34.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="492.7" spread="33.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="503.2" spread="36.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="483.2" spread="29.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="487.7" spread="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="483.6" spread="31.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="517.7" spread="33.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 AM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="490.5" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 PM, n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="509.1" spread="32.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 15 PM, Day 16, 17, 18, 19, 20, 21 AM and PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>BUD 800 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="578.0" spread="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="568.0" spread="37.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="572.0" spread="45.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="572.0" spread="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="558.0" spread="46.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="558.0" spread="45.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="568.0" spread="53.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="572.0" spread="46.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="584.0" spread="47.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="590.0" spread="37.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="590.0" spread="37.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="574.0" spread="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="606.0" spread="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>BUD 1600 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="506.4" spread="33.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="496.4" spread="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="512.7" spread="32.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="498.2" spread="34.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="510.5" spread="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.5" spread="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="514.1" spread="33.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="499.1" spread="31.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="512.3" spread="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="491.4" spread="31.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="497.7" spread="37.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="476.8" spread="27.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="526.8" spread="33.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>BUD 1600 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="594.0" spread="47.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="578.0" spread="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="586.0" spread="46.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="556.0" spread="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="556.0" spread="45.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="564.0" spread="50.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="594.0" spread="45.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="584.0" spread="45.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="568.0" spread="51.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="568.0" spread="52.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 27 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="584.0" spread="35.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28 AM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="574.0" spread="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28 PM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="630.0" spread="46.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 29 PM, Day 30, 31,32,33,34,35 AM and PM in period 1</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>BUD 3200 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 29 PM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="493.0" spread="31.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="482.0" spread="33.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 PM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="502.0" spread="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="482.0" spread="34.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31 PM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="496.0" spread="32.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="482.0" spread="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32 PM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="488.0" spread="33.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="483.0" spread="29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33 PM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="490.0" spread="35.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="489.0" spread="31.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34 PM, n=9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="522.2" spread="33.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35 AM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="474.0" spread="33.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35 PM, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="488.0" spread="30.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2</title>
        <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
        <time_frame>Day 29 PM, Day 30, 31,32,33,34,35 AM and PM in period 2</time_frame>
        <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>BUD 3200 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2</title>
          <description>PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.</description>
          <population>All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 29 PM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="596.0" spread="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 AM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="604.0" spread="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 PM, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="586.0" spread="41.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31 AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="562.5" spread="33.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31 PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="547.5" spread="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32 AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="592.5" spread="38.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32 PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="587.5" spread="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33 AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="567.5" spread="30.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 33 PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="565.0" spread="42.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34 AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="585.0" spread="38.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34 PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="583.8" spread="29.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35 AM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="577.5" spread="35.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35 PM, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="597.5" spread="38.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Abnormal Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
        <description>SBP and DBP were measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.</description>
        <time_frame>Up to Week 18</time_frame>
        <population>All subjects Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FF 25 mcg</title>
            <description>Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>FF 100 mcg</title>
            <description>Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>FF 200 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O5">
            <title>FF 400 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O6">
            <title>FF 800 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O7">
            <title>FP 50 mcg</title>
            <description>Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O8">
            <title>FP 200 mcg</title>
            <description>Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O9">
            <title>FP 500 mcg</title>
            <description>Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O10">
            <title>FP 1000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O11">
            <title>FP 2000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O12">
            <title>BUD 100 mcg</title>
            <description>Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O13">
            <title>BUD 400 mcg</title>
            <description>Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O14">
            <title>BUD 800 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O15">
            <title>BUD 1600 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O16">
            <title>BUD 3200 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Abnormal Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
          <description>SBP and DBP were measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.</description>
          <population>All subjects Population.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="0"/>
                <count group_id="O12" value="0"/>
                <count group_id="O13" value="0"/>
                <count group_id="O14" value="0"/>
                <count group_id="O15" value="0"/>
                <count group_id="O16" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Abnormal Vital Signs: Pulse Rate</title>
        <description>Pulse rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.</description>
        <time_frame>Up to Week 18</time_frame>
        <population>All subjects Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FF 25 mcg</title>
            <description>Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>FF 100 mcg</title>
            <description>Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>FF 200 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O5">
            <title>FF 400 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O6">
            <title>FF 800 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O7">
            <title>FP 50 mcg</title>
            <description>Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O8">
            <title>FP 200 mcg</title>
            <description>Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O9">
            <title>FP 500 mcg</title>
            <description>Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O10">
            <title>FP 1000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O11">
            <title>FP 2000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O12">
            <title>BUD 100 mcg</title>
            <description>Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O13">
            <title>BUD 400 mcg</title>
            <description>Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O14">
            <title>BUD 800 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O15">
            <title>BUD 1600 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O16">
            <title>BUD 3200 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Abnormal Vital Signs: Pulse Rate</title>
          <description>Pulse rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.</description>
          <population>All subjects Population</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="0"/>
                <count group_id="O12" value="0"/>
                <count group_id="O13" value="0"/>
                <count group_id="O14" value="0"/>
                <count group_id="O15" value="0"/>
                <count group_id="O16" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Abnormal Vital Signs: Respiratory Rate</title>
        <description>Respiratory rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.</description>
        <time_frame>Up to Week 18</time_frame>
        <population>All subjects Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FF 25 mcg</title>
            <description>Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>FF 100 mcg</title>
            <description>Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>FF 200 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O5">
            <title>FF 400 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O6">
            <title>FF 800 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O7">
            <title>FP 50 mcg</title>
            <description>Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O8">
            <title>FP 200 mcg</title>
            <description>Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O9">
            <title>FP 500 mcg</title>
            <description>Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O10">
            <title>FP 1000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O11">
            <title>FP 2000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O12">
            <title>BUD 100 mcg</title>
            <description>Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O13">
            <title>BUD 400 mcg</title>
            <description>Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O14">
            <title>BUD 800 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O15">
            <title>BUD 1600 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O16">
            <title>BUD 3200 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Abnormal Vital Signs: Respiratory Rate</title>
          <description>Respiratory rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.</description>
          <population>All subjects Population.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="0"/>
                <count group_id="O12" value="0"/>
                <count group_id="O13" value="0"/>
                <count group_id="O14" value="0"/>
                <count group_id="O15" value="0"/>
                <count group_id="O16" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Abnormal Vital Signs: Temperature</title>
        <description>Temperature was measured after participants have been rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.</description>
        <time_frame>Up to Week 18</time_frame>
        <population>All subjects Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FF 25 mcg</title>
            <description>Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>FF 100 mcg</title>
            <description>Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>FF 200 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O5">
            <title>FF 400 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O6">
            <title>FF 800 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O7">
            <title>FP 50 mcg</title>
            <description>Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O8">
            <title>FP 200 mcg</title>
            <description>Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O9">
            <title>FP 500 mcg</title>
            <description>Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O10">
            <title>FP 1000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O11">
            <title>FP 2000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O12">
            <title>BUD 100 mcg</title>
            <description>Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O13">
            <title>BUD 400 mcg</title>
            <description>Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O14">
            <title>BUD 800 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O15">
            <title>BUD 1600 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O16">
            <title>BUD 3200 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Abnormal Vital Signs: Temperature</title>
          <description>Temperature was measured after participants have been rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.</description>
          <population>All subjects Population.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="0"/>
                <count group_id="O12" value="0"/>
                <count group_id="O13" value="0"/>
                <count group_id="O14" value="0"/>
                <count group_id="O15" value="0"/>
                <count group_id="O16" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Physical Examination</title>
        <description>Physical examinations included assessment of the cardiovascular, respiratory, gastrointestinal, skin, abdomen (liver and spleen), and neurological systems. This analysis was planned and data was not collected and captured in the database. Results are presented treatment wise.</description>
        <time_frame>Up to Week 18</time_frame>
        <population>All subjects Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FF 25 mcg</title>
            <description>Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>FF 100 mcg</title>
            <description>Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>FF 200 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O5">
            <title>FF 400 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O6">
            <title>FF 800 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O7">
            <title>FP 50 mcg</title>
            <description>Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O8">
            <title>FP 200 mcg</title>
            <description>Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O9">
            <title>FP 500 mcg</title>
            <description>Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O10">
            <title>FP 1000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O11">
            <title>FP 2000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O12">
            <title>BUD 100 mcg</title>
            <description>Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O13">
            <title>BUD 400 mcg</title>
            <description>Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O14">
            <title>BUD 800 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O15">
            <title>BUD 1600 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O16">
            <title>BUD 3200 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Physical Examination</title>
          <description>Physical examinations included assessment of the cardiovascular, respiratory, gastrointestinal, skin, abdomen (liver and spleen), and neurological systems. This analysis was planned and data was not collected and captured in the database. Results are presented treatment wise.</description>
          <population>All subjects Population.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="0"/>
                <count group_id="O12" value="0"/>
                <count group_id="O13" value="0"/>
                <count group_id="O14" value="0"/>
                <count group_id="O15" value="0"/>
                <count group_id="O16" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Abnormal Hematology Parameters</title>
        <description>Blood samples were collected for assessement of following hematology parameters: basophils, eosinophils, Erythrocyte mean corpuscular volume (MCV), hemoglobin, hematocrit, Erythrocyte mean corpuscular hemoglobin (MCH), leukocytes, lymphocytes, monocytes, platelets. Results are presented treatment wise. Only participants with clinically significant abnormal hematology data was reported.</description>
        <time_frame>Up to Week 18</time_frame>
        <population>All subjects Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FF 25 mcg</title>
            <description>Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>FF 100 mcg</title>
            <description>Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>FF 200 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O5">
            <title>FF 400 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O6">
            <title>FF 800 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O7">
            <title>FP 50 mcg</title>
            <description>Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O8">
            <title>FP 200 mcg</title>
            <description>Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O9">
            <title>FP 500 mcg</title>
            <description>Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O10">
            <title>FP 1000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O11">
            <title>FP 2000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O12">
            <title>BUD 100 mcg</title>
            <description>Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O13">
            <title>BUD 400 mcg</title>
            <description>Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O14">
            <title>BUD 800 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O15">
            <title>BUD 1600 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O16">
            <title>BUD 3200 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Abnormal Hematology Parameters</title>
          <description>Blood samples were collected for assessement of following hematology parameters: basophils, eosinophils, Erythrocyte mean corpuscular volume (MCV), hemoglobin, hematocrit, Erythrocyte mean corpuscular hemoglobin (MCH), leukocytes, lymphocytes, monocytes, platelets. Results are presented treatment wise. Only participants with clinically significant abnormal hematology data was reported.</description>
          <population>All subjects Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="18"/>
                <count group_id="O6" value="18"/>
                <count group_id="O7" value="21"/>
                <count group_id="O8" value="20"/>
                <count group_id="O9" value="20"/>
                <count group_id="O10" value="18"/>
                <count group_id="O11" value="17"/>
                <count group_id="O12" value="18"/>
                <count group_id="O13" value="18"/>
                <count group_id="O14" value="18"/>
                <count group_id="O15" value="18"/>
                <count group_id="O16" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Abnormal Chemistry Parameters</title>
        <description>Blood samples were collecte for assessment of following chemistry parametres:Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, direct bilirubin, potassium, protein, sodium, urea. Results are presented treatment wise. Only participants with clinically significant abnormal chemistry data was reported.</description>
        <time_frame>Up to Week 18</time_frame>
        <population>All subjects Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FF 25 mcg</title>
            <description>Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>FF 100 mcg</title>
            <description>Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>FF 200 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O5">
            <title>FF 400 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O6">
            <title>FF 800 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O7">
            <title>FP 50 mcg</title>
            <description>Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O8">
            <title>FP 200 mcg</title>
            <description>Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O9">
            <title>FP 500 mcg</title>
            <description>Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O10">
            <title>FP 1000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O11">
            <title>FP 2000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O12">
            <title>BUD 100 mcg</title>
            <description>Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O13">
            <title>BUD 400 mcg</title>
            <description>Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O14">
            <title>BUD 800 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O15">
            <title>BUD 1600 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O16">
            <title>BUD 3200 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Abnormal Chemistry Parameters</title>
          <description>Blood samples were collecte for assessment of following chemistry parametres:Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, direct bilirubin, potassium, protein, sodium, urea. Results are presented treatment wise. Only participants with clinically significant abnormal chemistry data was reported.</description>
          <population>All subjects Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="18"/>
                <count group_id="O6" value="18"/>
                <count group_id="O7" value="21"/>
                <count group_id="O8" value="20"/>
                <count group_id="O9" value="20"/>
                <count group_id="O10" value="18"/>
                <count group_id="O11" value="17"/>
                <count group_id="O12" value="18"/>
                <count group_id="O13" value="18"/>
                <count group_id="O14" value="18"/>
                <count group_id="O15" value="18"/>
                <count group_id="O16" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Abnormal Urinalysis Parameters</title>
        <description>Urine sample were collected to assess following urine parameters: potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick. Results are presented treatment wise. Only participants with clinically significant abnormal urinalysis data was reported.</description>
        <time_frame>Up to Week 18</time_frame>
        <population>All subjects Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>FF 25 mcg</title>
            <description>Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>FF 100 mcg</title>
            <description>Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>FF 200 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O5">
            <title>FF 400 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O6">
            <title>FF 800 mcg</title>
            <description>Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O7">
            <title>FP 50 mcg</title>
            <description>Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O8">
            <title>FP 200 mcg</title>
            <description>Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O9">
            <title>FP 500 mcg</title>
            <description>Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O10">
            <title>FP 1000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O11">
            <title>FP 2000 mcg</title>
            <description>Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O12">
            <title>BUD 100 mcg</title>
            <description>Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O13">
            <title>BUD 400 mcg</title>
            <description>Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O14">
            <title>BUD 800 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O15">
            <title>BUD 1600 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
          </group>
          <group group_id="O16">
            <title>BUD 3200 mcg</title>
            <description>Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Abnormal Urinalysis Parameters</title>
          <description>Urine sample were collected to assess following urine parameters: potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick. Results are presented treatment wise. Only participants with clinically significant abnormal urinalysis data was reported.</description>
          <population>All subjects Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="18"/>
                <count group_id="O6" value="18"/>
                <count group_id="O7" value="21"/>
                <count group_id="O8" value="20"/>
                <count group_id="O9" value="20"/>
                <count group_id="O10" value="18"/>
                <count group_id="O11" value="17"/>
                <count group_id="O12" value="18"/>
                <count group_id="O13" value="18"/>
                <count group_id="O14" value="18"/>
                <count group_id="O15" value="18"/>
                <count group_id="O16" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Forced Expiratory Volume in 1 Second (FEV 1) in Period 1</title>
        <description>FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with American Thoracic Society (ATS) guidelines using European Respiratory Society (ERS)guidelines for predicted values. Results are presented treatment wise.</description>
        <time_frame>Day 1 (pre-dose) in Period 1</time_frame>
        <population>All Subjects Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Fluticasone Furoate (FF)</title>
            <description>Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.</description>
          </group>
          <group group_id="O3">
            <title>Fluticasone Propionate (FP)</title>
            <description>Participants received FP ELLIPTA 50 mg, 200 mcg, 500 mcg, 1000 mcg, 2000 mcg for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>Budesonide.</title>
            <description>Participants received Participants received BUD Turbuhaler 100 mcg, 400 mcg, 800 mcg, 1600 mcg, 3200 mcg as total daily dose for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Forced Expiratory Volume in 1 Second (FEV 1) in Period 1</title>
          <description>FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with American Thoracic Society (ATS) guidelines using European Respiratory Society (ERS)guidelines for predicted values. Results are presented treatment wise.</description>
          <population>All Subjects Population.</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.18" spread="0.151"/>
                    <measurement group_id="O2" value="3.02" spread="0.166"/>
                    <measurement group_id="O3" value="3.50" spread="0.269"/>
                    <measurement group_id="O4" value="3.29" spread="0.274"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Forced Expiratory Volume in 1 Second (FEV 1) in Period 2</title>
        <description>FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.</description>
        <time_frame>Day 1 (pre-dose) in Period 2</time_frame>
        <population>All Subjects Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Fluticasone Furoate (FF)</title>
            <description>Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.</description>
          </group>
          <group group_id="O3">
            <title>Fluticasone Propionate (FP)</title>
            <description>Participants received FP ELLIPTA 50 mg, 200 mcg, 500 mcg, 1000 mcg, 2000 mcg for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>Budesonide (BUD)</title>
            <description>Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Forced Expiratory Volume in 1 Second (FEV 1) in Period 2</title>
          <description>FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.</description>
          <population>All Subjects Population.</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.67" spread="0.482"/>
                    <measurement group_id="O2" value="3.44" spread="0.431"/>
                    <measurement group_id="O3" value="2.68" spread="0.278"/>
                    <measurement group_id="O4" value="3.46" spread="0.257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Forced Vital Capacity (FVC) in Period 1</title>
        <description>FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.</description>
        <time_frame>Day 1 (pre-dose) in Period 1</time_frame>
        <population>All Subjects Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Fluticasone Furoate (FF)</title>
            <description>Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.</description>
          </group>
          <group group_id="O3">
            <title>Fluticasone Propionate (FP)</title>
            <description>Participants received FP ELLIPTA 50 mg, 200 mcg, 500 mcg, 1000 mcg, 2000 mcg for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>Budesonide (BUD)</title>
            <description>Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Forced Vital Capacity (FVC) in Period 1</title>
          <description>FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.</description>
          <population>All Subjects Population.</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.55" spread="0.221"/>
                    <measurement group_id="O2" value="4.36" spread="0.222"/>
                    <measurement group_id="O3" value="5.15" spread="0.287"/>
                    <measurement group_id="O4" value="4.70" spread="0.406"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Forced Vital Capacity (FVC) in Period 2</title>
        <description>FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.</description>
        <time_frame>Day 1 (pre-dose) in Period 2</time_frame>
        <population>All Subjects Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Fluticasone Furoate (FF)</title>
            <description>Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.</description>
          </group>
          <group group_id="O3">
            <title>Fluticasone Propionate (FP)</title>
            <description>Participants received FP ELLIPTA 50 mg, 200 mcg, 500 mcg, 1000 mcg, 2000 mcg for 7 days.</description>
          </group>
          <group group_id="O4">
            <title>Budesonide (BUD)</title>
            <description>Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Forced Vital Capacity (FVC) in Period 2</title>
          <description>FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.</description>
          <population>All Subjects Population.</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.11" spread="0.570"/>
                    <measurement group_id="O2" value="4.85" spread="0.602"/>
                    <measurement group_id="O3" value="4.09" spread="0.386"/>
                    <measurement group_id="O4" value="4.90" spread="0.410"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious adverse events and non-serious adverse events were collected up to 18 weeks.</time_frame>
      <desc>All subjects Population was used to collect the adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.</description>
        </group>
        <group group_id="E2">
          <title>FF 25 mcg</title>
          <description>Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.</description>
        </group>
        <group group_id="E3">
          <title>FF 100 mcg</title>
          <description>Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.</description>
        </group>
        <group group_id="E4">
          <title>FF 200 mcg</title>
          <description>Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.</description>
        </group>
        <group group_id="E5">
          <title>FF 400 mcg</title>
          <description>Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.</description>
        </group>
        <group group_id="E6">
          <title>FF 800 mcg</title>
          <description>Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.</description>
        </group>
        <group group_id="E7">
          <title>FP 50 mcg</title>
          <description>Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.</description>
        </group>
        <group group_id="E8">
          <title>FP 200 mcg</title>
          <description>Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
        </group>
        <group group_id="E9">
          <title>FP 500 mcg</title>
          <description>Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
        </group>
        <group group_id="E10">
          <title>FP 1000 mcg</title>
          <description>Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
        </group>
        <group group_id="E11">
          <title>FP 2000 mcg</title>
          <description>Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
        </group>
        <group group_id="E12">
          <title>BUD 100 mcg</title>
          <description>Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.</description>
        </group>
        <group group_id="E13">
          <title>BUD 400 mcg</title>
          <description>Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
        </group>
        <group group_id="E14">
          <title>BUD 800 mcg</title>
          <description>Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.</description>
        </group>
        <group group_id="E15">
          <title>BUD 1600 mcg</title>
          <description>Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.</description>
        </group>
        <group group_id="E16">
          <title>BUD 3200 mcg</title>
          <description>Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA (21.1)</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="10" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="18"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E10" subjects_affected="8" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E12" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E13" subjects_affected="8" subjects_at_risk="18"/>
                <counts group_id="E14" subjects_affected="5" subjects_at_risk="18"/>
                <counts group_id="E15" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Eyelid oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E16" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Lip dry</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Saliva altered</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Catheter site bruise</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Catheter site related reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Catheter site swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Feeling jittery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Vessel puncture site bruise</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Post-traumatic neck syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Scratch</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="8" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E13" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E14" events="3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E15" events="3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E16" events="3" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Genital discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E16" events="2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Sinonasal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Sinus pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Keloid scar</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Tooth repair</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02991859
org study id: 203162
secondary id: 2016-003002-14
nct id: NCT02991859
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized, placebo-controlled, 2-period crossover, escalating repeat dose study,
      aiming to investigate whether higher potency of different inhaled corticosteroid confers an
      improvement in the topical efficacy to systemic activity ratio in asthmatic subjects. It will
      compare the dose response for topical efficacy via airway responsiveness (to
      adenosine-5'-monophosphate [AMP] challenge), and the dose response for systemic activity via
      24 hour plasma cortisol suppression, and thereby compare the relative therapeutic index, for
      the following inhaled corticosteroids: fluticasone furoate (FF), fluticasone propionate (FP)
      and budesonide (BUD). There will be a screening visit 4 - 42 days before the first dose of
      study treatment, and AMP challenge Provocative concentration 20 (PC20) of <=80 milligrams per
      milliliter (mg/mL) at screening visit 2 i.e. at 4 - 14 days before the first dose of study
      treatment. Subjects will be randomized to one of 5 or 12 treatment sequences, and will have
      one or two treatment periods, each comprising 5 consecutive 7-day phases of escalating doses
      of either FF, FP, BUD or placebo. There will be a 25- to 42-day washout period between
      treatment periods. The study duration for each subject will be approximately 13 or 24 weeks
      including the follow-up period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis
time frame: 12 hours post last dose on Day 7
description: The percentage fall in FEV1 was calculated using highest FEV1 (post saline) minus highest FEV1 (post AMP) divided by highest FEV1 (post saline)*100 where highest FEV1 (post saline) is the highest value of two FEV1 measurements at 60 and 180 seconds after the saline control, highest FEV1 (post AMP) is the highest value of the two FEV1 measurements at 60 and 180 seconds after the dose of AMP. Results are presented treatment wise. The analysis method was a 3 parameter Emax model with log 2 transformed AMP PC20 as the outcome variable, assuming common Emax across FF, FP and BUD, and with an unstructured variance-covariance matrix. Mean and 95% Confidence Interval (CI) presented are predicted estimate.
measure: Cortisol Suppression 0-24 Hours Weighted Mean-Dose Response Analysis
time frame: Pre-dose PM dose on Day 6 to pre-dose PM dose Day 7
description: Blood samples for measurement of plasma cortisol were collected at given time point. The weighted means were derived by calculating the area under the curve (AUC) over the 0-24-hour period using the trapezoidal rule, and then dividing it by the actual time interval. Results are presented treatment wise. Mean and 95% CI presented are predicted estimate. The analysis method was an inhibitory exponential power-law model with log e transformed cortisol as the outcome variable, assuming 100% inhibition at highest doses.
measure: Theraputic Index of FF
time frame: 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7
description: Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by Dose at which 80% of the maximum effect is reached (ED80) for AMP PC20 for FF 25 mcg, FF 100 mcg, FF 200 mcg, FF 400 mcg, FF 800 mcg. Theraputic index has been presented. Only those participants with data available at the specified time points were analyzed. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.
measure: Theraputic Index of FP
time frame: 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7
description: Therapeutic Index was calculated by Dose at which 20% of the maximum effect is reached (ED20) for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by ED80 for AMP PC20 for FP 50 mcg, FP 200 mcg, FP 500 mcg, FP 1000 mcg, FP 2000 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.
measure: Theraputic Index of BUD
time frame: 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7
description: Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by ED80 for AMP PC20 for BUD 100 mcg, BUD 400 mcg, BUD 800 mcg, BUD 1600 mcg, BUD 3200 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.
measure: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
time frame: Up to Week 18
description: An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that at any dose results in death, Is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
time frame: Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
measure: PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
time frame: Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in Period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.
measure: PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1
time frame: Day 2,3,4,5,6,7 PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2
time frame: Day 2,3,4,5,6,7 PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1
time frame: Day 8,9,10,11,12,13,14 PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2
time frame: Day 8,9,10,11,12,13,14 PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1
time frame: Day 15,16,17,18,19,20,21 PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2
time frame: Day 15,16,17,18,19,20 PM, Day 21 AM and PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1
time frame: Days 22,23,24,25,26,27,28 PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2
time frame: Days 22,23,24,25,26,27,28 PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1
time frame: Days 29,30,31,32,33,34,35 PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2
time frame: Day 29,30,31,32,33,34,35 PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 1
time frame: Day 2,3,4,5,6,7 PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
time frame: Day 2,3,4,5,6,7 AM and PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
time frame: Days 8,9,1,0,11,12,13,14 AM and PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
time frame: Day 8,9,1,0,11,12,13,14 AM and PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
time frame: Day 15 PM, Day 16,17,18,19,20,21,22,23,24,25,26,27,28 AM and PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
time frame: Day 15 PM, Day 16,17,18,19,20,21 AM and PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
time frame: Day 22 PM, Day 23,24,25,26,27,28,29,30,31,32,33,34,35 AM and PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
time frame: Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
time frame: Day 29 PM, Day 30,31,32,33,34,35 AM and PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
time frame: Day 29 PM, Day 30,31,32,33,34,35 AM and PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1
time frame: Day 2 to 6 AM and PM, Day 7 PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 2
time frame: Day 2,3,4,5,6,7 PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
time frame: Day 8 PM, Day 9 to 14 AM and PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
time frame: Day 8 PM, Day 9 to 14 AM and PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
time frame: Day 15,16, 17, 18, 19, 20, 21 AM and PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
time frame: Day 15 PM, Day 16, 17, 18, 19, 20, 21 AM and PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
time frame: Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
time frame: Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
time frame: Day 29 PM, Day 30, 31,32,33,34,35 AM and PM in period 1
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
time frame: Day 29 PM, Day 30, 31,32,33,34,35 AM and PM in period 2
description: PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
measure: Number of Participants With Clinically Significant Abnormal Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
time frame: Up to Week 18
description: SBP and DBP were measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
measure: Number of Participants With Clinically Significant Abnormal Vital Signs: Pulse Rate
time frame: Up to Week 18
description: Pulse rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
measure: Number of Participants With Clinically Significant Abnormal Vital Signs: Respiratory Rate
time frame: Up to Week 18
description: Respiratory rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
measure: Number of Participants With Clinically Significant Abnormal Vital Signs: Temperature
time frame: Up to Week 18
description: Temperature was measured after participants have been rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
measure: Number of Participants With Abnormal Physical Examination
time frame: Up to Week 18
description: Physical examinations included assessment of the cardiovascular, respiratory, gastrointestinal, skin, abdomen (liver and spleen), and neurological systems. This analysis was planned and data was not collected and captured in the database. Results are presented treatment wise.
measure: Number of Participants With Clinically Significant Abnormal Hematology Parameters
time frame: Up to Week 18
description: Blood samples were collected for assessement of following hematology parameters: basophils, eosinophils, Erythrocyte mean corpuscular volume (MCV), hemoglobin, hematocrit, Erythrocyte mean corpuscular hemoglobin (MCH), leukocytes, lymphocytes, monocytes, platelets. Results are presented treatment wise. Only participants with clinically significant abnormal hematology data was reported.
measure: Number of Participants With Clinically Significant Abnormal Chemistry Parameters
time frame: Up to Week 18
description: Blood samples were collecte for assessment of following chemistry parametres:Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, direct bilirubin, potassium, protein, sodium, urea. Results are presented treatment wise. Only participants with clinically significant abnormal chemistry data was reported.
measure: Number of Participants With Clinically Significant Abnormal Urinalysis Parameters
time frame: Up to Week 18
description: Urine sample were collected to assess following urine parameters: potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick. Results are presented treatment wise. Only participants with clinically significant abnormal urinalysis data was reported.
measure: Forced Expiratory Volume in 1 Second (FEV 1) in Period 1
time frame: Day 1 (pre-dose) in Period 1
description: FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with American Thoracic Society (ATS) guidelines using European Respiratory Society (ERS)guidelines for predicted values. Results are presented treatment wise.
measure: Forced Expiratory Volume in 1 Second (FEV 1) in Period 2
time frame: Day 1 (pre-dose) in Period 2
description: FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.
measure: Forced Vital Capacity (FVC) in Period 1
time frame: Day 1 (pre-dose) in Period 1
description: FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.
measure: Forced Vital Capacity (FVC) in Period 2
time frame: Day 1 (pre-dose) in Period 2
description: FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.
arm group label: Arm AB - FF followed by FP
arm group type: Experimental
description: Each treatment period (TP) comprises of 5 consecutive 7-day dosing phases with escalating doses of either FF or FP. In TP 1, subjects will receive evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose [TDD] = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period will be of 25-42 days.
arm group label: Arm AC - FF followed by BUD
arm group type: Experimental
description: Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FF or BUD. In TP 1, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD = 100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD = 1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period will be of 25-42 days.
arm group label: Arm AD - FF followed by ELLIPTA Placebo
arm group type: Experimental
description: Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FF or ELLIPTA Placebo. In TP 1, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. Washout period will be of 25-42 days.
arm group label: Arm BA - FP followed by FF
arm group type: Experimental
description: Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FP or FF. In TP 1, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period will be of 25-42 days.
arm group label: Arm BC - FP followed by BUD
arm group type: Experimental
description: Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FP or BUD. In TP 1, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period will be of 25-42 days.
arm group label: Arm BE - FP followed by DISKUS Placebo
arm group type: Experimental
description: Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either FP or DISKUS Placebo. In TP 1, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Each TP will be followed by a washout period of 25-42 days.
arm group label: Arm CA - BUD followed by FF
arm group type: Experimental
description: Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either BUD or FF. In TP 1, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period will be of 25-42 days.
arm group label: Arm CB - BUD followed by FP
arm group type: Experimental
description: Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either BUD or FP. In TP 1, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD =500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period will be of 25-42 days.
arm group label: Arm CE - BUD followed by DISKUS Placebo
arm group type: Experimental
description: Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either BUD or DISKUS Placebo. In TP 1, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; and AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Washout period will be of 25-42 days.
arm group label: Arm DA - ELLIPTA Placebo followed by FF
arm group type: Experimental
description: Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either ELLIPTA Placebo or FF. In TP 1, subjects will receive PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period will be of 25-42 days.
arm group label: Arm EB - DISKUS Placebo followed by FP
arm group type: Experimental
description: Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either DISKUS Placebo or FP. TP 1, subjects will receive PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each of DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period will be of 25-42 days.
arm group label: Arm DC - ELLIPTA Placebo followed by BUD
arm group type: Experimental
description: Each TP comprises of 5 consecutive 7-day dosing phases with escalating doses of either ELLIPTA Placebo or BUD. In TP 1, subjects will receive PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, subjects will receive PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period will be of 25-42 days.
intervention type: Drug
intervention name: Fluticasone furoate (FF) Dry Powder Inhaler
description: Dry inhalation powder 25 mcg, 100 mcg, and 200 mcg per blister strip will be administered using ELLIPTA for both treatment periods
arm group label: Arm AB - FF followed by FP
arm group label: Arm AC - FF followed by BUD
arm group label: Arm AD - FF followed by ELLIPTA Placebo
arm group label: Arm BA - FP followed by FF
arm group label: Arm CA - BUD followed by FF
arm group label: Arm DA - ELLIPTA Placebo followed by FF
intervention type: Drug
intervention name: Fluticasone propionate (FP) Dry Powder Inhaler
description: Dry Inhalation powder 50 mcg, 100 mcg, 250 mcg, and 500 mcg per blister strip will be administered using DISKUS for both treatment periods
arm group label: Arm AB - FF followed by FP
arm group label: Arm BA - FP followed by FF
arm group label: Arm BC - FP followed by BUD
arm group label: Arm BE - FP followed by DISKUS Placebo
arm group label: Arm CB - BUD followed by FP
arm group label: Arm EB - DISKUS Placebo followed by FP
intervention type: Drug
intervention name: Budesonide (BUD) Turbuhaler
description: Budesonide comprises white to off-white rounded granules, which disintegrate to a fine powder upon slight pressure, will be administered using Turbuhaler for both treatment periods.
arm group label: Arm AC - FF followed by BUD
arm group label: Arm BC - FP followed by BUD
arm group label: Arm CA - BUD followed by FF
arm group label: Arm CB - BUD followed by FP
arm group label: Arm CE - BUD followed by DISKUS Placebo
arm group label: Arm DC - ELLIPTA Placebo followed by BUD
intervention type: Drug
intervention name: Placebo (ELLIPTA or DISKUS)
description: Lactose dry powder inhaler will be administered using ELLIPTA or DISKUS for both treatment periods.
arm group label: Arm AD - FF followed by ELLIPTA Placebo
arm group label: Arm BE - FP followed by DISKUS Placebo
arm group label: Arm CE - BUD followed by DISKUS Placebo
arm group label: Arm DA - ELLIPTA Placebo followed by FF
arm group label: Arm DC - ELLIPTA Placebo followed by BUD
arm group label: Arm EB - DISKUS Placebo followed by FP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
country: Germany
country: United Kingdom
responsible party type: Sponsor
mesh term: Asthma
mesh term: Fluticasone
mesh term: Xhance
mesh term: Budesonide
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: https://clinicalstudydatarequest.com/Posting.aspx?ID=20386
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 