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       Item: 
        Title: Methods
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       Item: 
        Title: Discussion
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       Item: 
        Title: Trial registration
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      Title: Background
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     Item: 
      Title: Methods
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       Item: 
        Title: Randomization
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       Item: 
        Title: Masking
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       Item: 
        Title: Experimental and control groups
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       Item: 
        Title: Inclusion and exclusion criteria
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       Item: 
        Title: Study population and total number of patients
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       Item: 
        Title: Outcome variables
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       Item: 
        Title: Enrollment
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          Title: Initial visit
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          Title: Follow-up
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        Title: Data analysis
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         Item: 
          Title: Ethical issues
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          Title: Other considerations
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      Title: Additional files
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      Title: Acknowledgments
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