Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent Asthma
Brief Summary: The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.


Options:
A: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
B: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) (From Day 1 up to 6 months); Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period (From Day 1 up to 6 months)
C: Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1) (Day 15 of each treatment period (up to Study Day 71)); Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period (Day 15 of each treatment period (up to Study Day 71)); Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) (From Baseline until the end of Treatment Period 3 (up to Study Day 70)); Number of Participants With Asthma Exacerbations During the Treatment Period (From Baseline until the end of Treatment Period 3 (up to Study Day 70)); Change From Baseline in Systolic Blood Pressure on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in Diastolic Blood Pressure on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in Pulse Rate on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in Albumin, Total Protein, and Hemoglobin on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70))); Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (ANC - Absolute Neutrophil Count), Platelet, and Leukocytes Count on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in Hematocrit on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70))); Urine pH on Day 14 of Each Treatment Period (Day 14 of each treatment period (up to Study Day 70)); Urine Specific Gravity on Day 14 of Each Treatment Period (Day 14 of each treatment period (up to Study Day 70)); Number of Participants With the Indicated Abnormal Electrocardiogram Findings (Day 14 of each treatment period (up to Study Day 70)); Number of Participants With the Indicated 24 Hour Holter Findings (Day 14 of each treatment period (up to Study Day 70))
D: Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period (Day 1 to Week 26 of the Treatment Period)

Answer: B