Title and abstract |
|
1a |
Identification as a randomised trial in the title |
Title |
1b |
Structured summary of trial design, methods, results, and conclusions |
1 |
Introduction |
Background and objectives |
2a |
Scientific background and explanation of rationale |
2 |
2b |
Specific objectives or hypotheses |
2 |
Methods |
Trial design |
3a |
Description of trial design (such as parallel, factorial) including allocation ratio |
2 |
3b |
Important changes to methods after trial commencement (such as eligibility criteria), with reasons |
3 & 4 |
Participants |
4a |
Eligibility criteria for participants |
3 |
4b |
Settings and locations where the data were collected |
2--3 |
Interventions |
5 |
The interventions for each group with sufficient details to allow replication, including how and when they were actually administered |
3 |
Outcomes |
6a |
Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed |
3 |
6b |
Any changes to trial outcomes after the trial commenced, with reasons |
None |
Sample size |
7a |
How sample size was determined |
4 |
7b |
When applicable, explanation of any interim analyses and stopping guidelines |
Not applicable |
Randomisation: |
|
|
|
Sequence generation |
8a |
Method used to generate the random allocation sequence |
3 |
8b |
Type of randomisation; details of any restriction (such as blocking and block size) |
3 |
Allocation concealment mechanism |
9 |
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 |
3 |
Implementation |
10 |
Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions |
3 |
Blinding |
11a |
If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how |
3 |
11b |
If relevant, description of the similarity of interventions |
3 |
Statistical methods |
12a |
Statistical methods used to compare groups for primary and secondary outcomes |
4 |
12b |
Methods for additional analyses, such as subgroup analyses and adjusted analyses |
3 & 4 |
Results |
Participant flow (a diagram is strongly recommended) |
13a |
For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome |
4 & Figure 1 (flow diagram) |
13b |
For each group, losses and exclusions after randomisation, together with reasons |
Figure 1 (flow diagram) |
Recruitment |
14a |
Dates defining the periods of recruitment and follow-up |
Figure 1 (flow diagram) |
14b |
Why the trial ended or was stopped |
4 & 9 |
Baseline data |
15 |
A table showing baseline demographic and clinical characteristics for each group |
Table 1
|
Numbers analysed |
16 |
For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups |
4 & Figure 1 (flow diagram) |
Outcomes and estimation |
17a |
For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) |
4–6 |
17b |
For binary outcomes, presentation of both absolute and relative effect sizes is recommended |
Not applicable |
Ancillary analyses |
18 |
Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory |
4 & 6 |
Harms |
19 |
All important harms or unintended effects in each group |
6 |
Discussion |
Limitations |
20 |
Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses |
9 |
Generalisability |
21 |
Generalisability (external validity, applicability) of the trial findings |
9 |
Interpretation |
22 |
Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence |
6 & 8--9 |
Other information |
|
Registration |
23 |
Registration number and name of trial registry |
9 |
Protocol |
24 |
Where the full trial protocol can be accessed, if available |
4 & 9 |
Funding |
25 |
Sources of funding and other support (such as supply of drugs), role of funders |
9 |