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Table 1 Protocol Schedule and Activities

From: Efficacy and tolerability of an undenatured type II collagen supplement in modulating knee osteoarthritis symptoms: a multicenter randomized, double-blind, placebo-controlled study

Procedures common to both protocols Screening (Visit 1) Study period
Day 1 (Baseline Visit 2) Days 7, 30, 60, 90, 120, 150 (Visits 3, 4, 5, 6, 7, 8) Day 180 (Visit 9)
Signed Informed Consent X    
Inclusion/Exclusion Reviewed X X X  
Medical/Surgical/Medication History X    
Physical Examination X    
Vital Signs X X X X
Heighta, 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
  1. aHeight was measured only at Visit 1