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Title of article:

Authors:

Introduction

Background—Scientific background and explanation of the rationale

  • Summarize the background information:

Methods

Study design (circle)

  • Randomized, double-blind, placebo-controlled, multicenter trial, single-center trial, other

Endpoints

  • Primary endpoint:

  • Secondary endpoint:

  • Other endpoints:

Study population

  • Inclusion criteria

  • Exclusion criteria

  • Location of the study:

Interventions

  • Medication:

  • Formulation:

  • Dose and frequency:

Statistics

Sample size calculation—Yes/No

If yes, describe the method:

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Analysis methods:
Outcomes Measurement Parameters Test (eg, t-test, ANOVA)
Primary outcome (1° OC):    
Secondary outcome (2° OC):    
Other outcome(s):    

Results

Efficacy

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Analysis methods:
Outcomes Results Significance (p-value)
Primary outcome (1° OC):    
Secondary outcome (2° OC):    
Other outcome(s):    

Safety

Harms during study (adverse events):

Discussion

Study limitations

Generalizability (external validity)

Author’s conclusion

Your own interpretation

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