Table 1 Overall Reporting Quality items

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.