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. 2010 Feb 5;10:11. doi: 10.1186/1471-2288-10-11

Table 1.

Overall Reporting Quality items

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

* Item 6 (Objectives) was excluded from OQS.