1. Title and Abstract
- Indicate the study's design with a commonly used term in the title or the abstract.
- Provide a structured summary of study design, methods, results, and conclusions.
2. Introduction
- Explain the scientific background and rationale for the investigation.
- State specific objectives, including any pre-specified hypotheses.
3. Methods
- Present key elements of study design early in the paper.
- Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection.
- Clearly define eligibility criteria, and the sources and methods of selection of participants.
- Clearly define the outcomes, any exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable.
- Describe the methods of assessment for each variable or a reference if it's a standard method.
- Describe any efforts to address potential sources of bias.
- Explain how quantitative variables were handled in the analyses.
- Describe all statistical methods, including those used to control for confounding.
- Describe any sensitivity analyses.
4. Results
- Report the numbers of individuals at each stage of the study.
- Give reasons for non-participation at each stage.
- Consider use of a flow diagram.
- Provide a descriptive analysis of the data.
- Report outcome data and a summary of the main findings.
- Give estimates of the random variability for important outcomes.
- Report all important adverse events or side effects.
5. Discussion
- Summarize key results with reference to study objectives.
- Discuss limitations of the study, taking into account sources of potential bias or imprecision.
- Discuss the generalizability (external validity) of the study results.
6. Other Information
- If relevant, describe funding sources and the role of funders for the present study.
- Indicate if there were any pre-specified analyses.
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