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Total 

Group A 

Group B

Randomised

N=



Randomised in error   

  • Not eligible
  • No consent       

n (% randomised)



Received allocated intervention

n (% randomised)



Did not receive allocated intervention

  • Died before intervention
  • Withdrawn before intervention
  • Intervention not administered, other reasons
  • Incorrect intervention
  • Intervention discontinued
  • Non-compliant

n (% randomised)


 


 

 

 


 

 

 


 

Declined under waiver  

n (% randomised)

Consented           

n (% randomised)

 

Include in intention to treat (ITT) analysis    

n (% randomised)


 

 

Assessments

Primary Outcome Assessment 

Total 

Group A 

Group B

Reached minimum assessment age

N= 


 

Withdrawn 

n (% min age) 

 

Lost

n (% min age)



Reduced participation 

n (% min age)



Overseas 

n (% min age) 

  
 Died

n (% min age)

--

Primary outcome available

% of ITT analysis group

n (% min age)


 

Other Assessment 1 (optional) 

  
 

Reached minimum assessment age

N=



Withdrawn

n  (% min age)

  

Lost

n  (% min age) 



Reduced participation

n (% min age)



Overseas

n (% min age)

 

Died

n (% min age)

-

-

Specific tests (if required) 

n (% min age) 



Other Assessment 2 (optional)

 
 
 

Reached minimum assessment age

N=



Withdrawn  

n (% min age)

  

Lost  

n (% min age) 

  

Reduced participation

n (% min age)



Overseas

n (% min age)



Died

n (% min age)

-

-

Specific tests (if required)

n (% min age)