Table 1 Protocol Schedule and Activities

Signed Informed Consent

X

Inclusion/Exclusion Reviewed

X

X

X

Medical/Surgical/Medication History

X

Physical Examination

X

Vital Signs

X

X

X

X

Height^a, Weight, BMI

X

X

Clinical Assessment for Knee Pain & Swelling

X

X

X

X

Knee Flexion Range of Motion

X

X

X

X-ray examination

X

WOMAC Score

X

X

X

X

VAS Scale

X

X

X

X

LFI Score

X

X

X

X

Clinical Laboratory Tests (hematology, chemistry, urinalysis)

X

X

Urine Pregnancy Test (if applicable)

X

X

X

Serum biomarker analysis-COMP

X

X

Randomization Number Assigned

X

Investigational Product Administration

X

Dispense Subject Diary

X

X

Collect/Review Subject Diary

X

X

Provide Directions for Concomitant Medication and Rescue Medication Use

X

X

X

Dispense New Investigational Product

X

X

Review Product Accountability

X

X

Assess use of Concomitant Medications

X

X

X

Adverse Events Assessed

X

X

X

Procedures Confined to Protocol 003348

Synovial fluid biomarker—MMP-3 and IL-6

X

X

Serum biomarker analysis—CRP

X

X