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090177e1969f145c\Final\Final On: 25-Mar-2021 15:04 (GMT) 
   
       
         
   
       
        
   
    
  
        
    
 
 
 
 
 
   
   
 
 
 
 
   
              
       
    
     
       
   
            
   
    
    
     
    
         
   
   
     
       
      
   
   
   
  
    
   
  
   
   
     
  
      
  
FDA-CBER-2021-5683-0013853
090177e1969f145c\Final\Final On: 25-Mar-2021 15:04 (GMT)    
    
    
   
         
   
             
              
   
       
    
   
      
       
      
   
   
   
  
    
   
  
   
   
     
  
       
  
FDA-CBER-2021-5683-0013854