Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I Study of GW642444M- A Randomized, Double Blind, Placebo Controlled, Parallel-group, 7 Day Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Dose of GW642444M From a Novel Dry Powder Device in Healthy Japanese Male Subjects -
Brief Summary: This is a randomized, double blind, placebo controlled, parallel-group, 7 day repeat dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dose of GW642444M from a novel dry powder device in healthy Japanese male subjects.


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 With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period (From the first dose of the study medication until the Follow-up Visit (up to Study Day 60)); Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period (Baseline and Day 1 of each treatment period (up to Study Day 54))
C: Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period (Baseline and Weeks 1-12 (up to Day 84))
D: Safety：adverse events, vital sign, ECGs, and clinical laboratory test; PK：Cmax, tmax and AUC(0-t)

Answer: D