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1. Title or Abstract
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The title or the abstract states the study is a randomized controlled trial.
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2. Introduction
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Appropriate description of the scientific background and explanation of the rationale.
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Methods:
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3. Participants
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Eligibility criteria for participants are clearly described.
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4. Interventions
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Precise details of the interventions intended in each group are provided.
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5. Outcomes
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Clear definition of primary and secondary outcome measures is provided.
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6. Objectives
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Specific objectives or research question or hypotheses are stated.
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7. Sample size
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Clear description on how the sample size was determined is given.
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8. Randomization sequence generation
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The method used to generate the random allocation sequence is stated.
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9. Randomization implementation
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The separation of generator of the allocation sequence and executor is described.
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10. Statistical methods
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Statistical methods used to compare groups for primary outcomes, subgroup analyses or adjusted analyses were properly described.
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Results:
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11. Participants flow
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Number of participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for primary outcome are given.
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12. Recruitment
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Dates defining the periods of recruitment and follow-up are provided.
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13. Baseline data
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Baseline demographic and clinical characteristics of each group are properly described.
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14. Outcomes and estimation
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For each primary and secondary outcome, a summary of results for each group and the estimated effect size and its precision (e.g., 95% CI) is provided.
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15. Adverse events
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All important adverse events or side effects in each intervention group are described.
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