Item

Section/Topic Checklist item

No
Title and
abstract
1a Identification as a randomised trial in the title
Structured summary of trial design, methods, results, and
1b
conclusions (for specific guidance see CONSORT for abstracts)
Introduction
Background and
2a Scientific background and explanation of rationale
objectives
2b Specific objectives or hypotheses
Methods
Description of trial design (such as parallel, factorial) including
Trial design 3a
allocation ratio
Important changes to methods after trial commencement (such as
3b
eligibility criteria), with reasons
Participants 4a Eligibility criteria for participants
4b Settings and locations where the data were collected
The interventions for each group with sufficient details to allow
Interventions 5 replication, including how and when they were actually
administered
Completely defined pre-specified primary and secondary outcome
Outcomes 6a
measures, including how and when they were assessed
Any changes to trial outcomes after the trial commenced, with
6b
reasons
Sample size 7a How sample size was determined
When applicable, explanation of any interim analyses and stopping
7b
guidelines

Randomisation:

Sequence 8a Method used to generate the random allocation sequence

generation

Type of randomisation; details of any restriction (such as blocking

8b
and block size)
 Mechanism used to implement the random allocation sequence
Allocation
9 (such as sequentially numbered containers), describing any steps
concealment
taken to conceal the sequence until interventions were assigned
mechanism

Who generated the random allocation sequence, who enrolled

10
Implementation participants, and who assigned participants to interventions
If done, who was blinded after assignment to interventions (for
Blinding 11a example, participants, care providers, those assessing outcomes)
and how
11b If relevant, description of the similarity of interventions
Statistical Statistical methods used to compare groups for primary and
12a
methods secondary outcomes
Methods for additional analyses, such as subgroup analyses and
12b
adjusted analyses
Results

Participant flow
For each group, the numbers of participants who were randomly
(a diagram is
13a assigned, received intended treatment, and were analysed for the
strongly
primary outcome
recommended)

For each group, losses and exclusions after randomisation, together

13b
with reasons
Recruitment 14a Dates defining the periods of recruitment and follow-up
14b Why the trial ended or was stopped
A table showing baseline demographic and clinical characteristics
Baseline data 15
for each group
For each group, number of participants (denominator) included in
Numbers
16 each analysis and whether the analysis was by original assigned
analysed
groups
For each primary and secondary outcome, results for each group,
Outcomes and
17a and the estimated effect size and its precision (such as 95%
estimation
confidence interval)
For binary outcomes, presentation of both absolute and relative
17b
effect sizes is recommended
Results of any other analyses performed, including subgroup
Ancillary
18 analyses and adjusted analyses, distinguishing pre-specified from
analyses
exploratory
All important harms or unintended effects in each group (for
Harms 19
specific guidance see CONSORT for harms)
Discussion
 Trial limitations, addressing sources of potential bias, imprecision,
Limitations 20
and, if relevant, multiplicity of analyses

Generalisability 21 Generalisability (external validity, applicability) of the trial findings

Interpretation consistent with results, balancing benefits and harms,

Interpretation 22
and considering other relevant evidence
Other
information
Registration 23 Registration number and name of trial registry
Protocol 24 Where the full trial protocol can be accessed, if available
Sources of funding and other support (such as supply of drugs), role
Funding 25
of funders