Section/Topic |
Item No |
Checklist item |
Reported on page
No |
Title and abstract |
Title and abstract |
Title and abstract |
Title and
abstract |
|
1a |
Identification as a randomised trial in the title |
Page
1 |
|
1b |
Structured summary of trial design, methods, results, and
conclusions (for specific guidance see CONSORT for abstracts) |
Page
1 |
Introduction |
Introduction |
Introduction |
Introduction |
Background and objectives |
2a |
Scientific background and explanation
of rationale |
Page 2 |
|
2b |
Specific objectives or hypotheses |
Page 2 |
Methods |
Methods |
Methods |
Methods |
Trial design |
3a |
Description of trial design (such as parallel,
factorial) including allocation ratio |
Page 3-4 |
|
3b |
Important changes to methods after trial commencement (such as
eligibility criteria), with reasons |
Page 3-4 |
Participants |
4a |
Eligibility criteria for participants |
Page
3-4 |
|
4b |
Settings and locations where the data were collected |
Page
3-4 |
Interventions |
5 |
The interventions for each group with sufficient
details to allow replication, including how and when they were actually
administered |
Page 3-4 |
Outcomes |
6a |
Completely defined pre-specified primary and secondary
outcome measures, including how and when they were assessed |
Page
3-4 |
|
6b |
Any changes to trial outcomes after the trial commenced, with
reasons |
Page 3-4 |
Sample size |
7a |
How sample size was determined |
Page
3-4 |
|
7b |
When applicable, explanation of any interim analyses and stopping
guidelines |
Page 3-4 |
Randomisation: |
|
|
|
Sequence generation |
8a |
Method used to generate the random
allocation sequence |
Page 3-4 & Fig 1 |
|
8b |
Type of randomisation; details of any restriction (such as
blocking and block size) |
Page 3-4 & Fig 1 |
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 |
Page 3-4 & Fig 1 |
Implementation |
10 |
Who generated the random allocation sequence, who
enrolled participants, and who assigned participants to interventions |
Page 3-4 & Fig 1 |
Blinding |
11a |
If done, who was blinded after assignment to
interventions (for example, participants, care providers, those
assessing outcomes) and how |
Page 3-4 & Fig 1 |
|
11b |
If relevant, description of the similarity of interventions |
Page 3-4 & Fig 1 |
Statistical methods |
12a |
Statistical methods used to compare groups
for primary and secondary outcomes |
Page 3-4 |
|
12b |
Methods for additional analyses, such as subgroup analyses and
adjusted analyses |
Page 3-4 |
Results |
Results |
Results |
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 |
Page
5-6 |
|
13b |
For each group, losses and exclusions after randomisation,
together with reasons |
Page 5-6 |
Recruitment |
14a |
Dates defining the periods of recruitment and
follow-up |
Page 5-6 |
|
14b |
Why the trial ended or was stopped |
Page 5-6 |
Baseline data |
15 |
A table showing baseline demographic and clinical
characteristics for each group |
Page 5-6 |
Numbers analysed |
16 |
For each group, number of participants
(denominator) included in each analysis and whether the analysis was by
original assigned groups |
Page 5-6 |
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) |
Page 5-6 |
|
17b |
For binary outcomes, presentation of both absolute and relative
effect sizes is recommended |
- |
Ancillary analyses |
18 |
Results of any other analyses performed,
including subgroup analyses and adjusted analyses, distinguishing
pre-specified from exploratory |
- |
Harms |
19 |
All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms) |
- |
Discussion |
Discussion |
Discussion |
Discussion |
Limitations |
20 |
Trial limitations, addressing sources of potential
bias, imprecision, and, if relevant, multiplicity of analyses |
Page
7-8 |
Generalisability |
21 |
Generalisability (external validity,
applicability) of the trial findings |
Page 6-7 |
Interpretation |
22 |
Interpretation consistent with results, balancing
benefits and harms, and considering other relevant evidence |
Page
6-7 |
Other information |
Other information |
Other information |
|
Registration |
23 |
Registration number and name of trial registry |
Page 5 |
Protocol |
24 |
Where the full trial protocol can be accessed, if
available |
Page 5 |
Funding |
25 |
Sources of funding and other support (such as supply of
drugs), role of funders |
- |