Table 1 Changes in CONSORT checklist item

Identification as a randomized trial in the title

1

1*

1a^†

Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)

2

-

1b^†

Introduction

Scientific background and explanation of rationale

-

2

2a

Specific objectives or hypotheses

3

5*

2b

Methods

Description of trial design (such as parallel, factorial), including allocation ratio

-

-

3a

Important changes to methods after trial commencement (such as eligibility, criteria), with reasons

-

-

3b

Eligibility criteria for participants

4

3*

4a*

Settings and locations where the data were collected

-

4b*

The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

5

4*

5*

Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed

6

6*

6a*

Any changes to trial outcomes after the trial commenced, with reasons

-

-

6b

How sample size was determined

6

7*

7a*

When applicable, explanation of any interim analyses and stopping guidelines

8

7b*

Randomization

Sequence generation

Method used to generate the random allocation sequence

10

8*

8a^†

Type of randomization; details of any restriction (such as blocking and block size)

9

8b^†

Allocation concealment mechanism

Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned

11

9*

9*

Implementation

Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions

12

10*

10^†

If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how

13

11*

11a*

If relevant, description of the similarity of interventions

11b*

Statistical methods used to compare groups for primary

7

12*

12a*

and secondary outcomes

-

-

Methods for additional analyses, such as subgroup analyses and adjusted analyses

3

12*

12b*

Results

For each group, the numbers of participants who were randomly assigned received intended treatment, and were analyzed for the primary outcome

14

13*

13a^†

For each group, losses and exclusions after randomization, together with reasons

19

13b^†

Dates defining the periods of recruitment and follow-up

-

14

14a*

Why the trial ended or was stopped

-

14b

A table showing baseline demographic and clinical characteristics for each group

-

15

15^†

For each group, the number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

16

16*

16^†

For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

15

17*

17a*

For binary outcomes, presentation of both absolute and relative effect sizes is recommended

18

17b*

Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory

17

18*

18^†

All important harms or unintended effects (for specific guidance see CONSORT for harms)

-

19

19^†

Discussion

Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

20

20*

20*

Generalizability (external validity, applicability) of the trial findings

21*

21^†

Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence

21

22*

22*

Other information

Registration number and name of trial registry

-

-

23

Where the full trial protocol can be accessed, if available

-

-

24

Sources of funding and other support (such as supply of drugs), role of funders

-

-

25