Heading

Subheading

Descriptor

Was it reported?

Identify the study as a randomised trial

 Yes

Abstract

Use a structured format.

 Yes

State prospectively defined hypothesis, clinical objectives, and planned subgroup or covariate analyses.

 Yes

Methods

Protocol

Describe:
Planned study population together with inclusion/exclusion criteria.
Planned interventions and their timing._
Primary and secondary outcome measure(s) and the minimum important difference(s), and indicate how the target sample size was projected.
Rationale and methods for statistical analyses, detailing main comparative analyses and whether they were completed on an intention-to-treat basis.
Prospectively defined stopping rules (if warranted)

 

Yes

Yes

 

 

Yes

Yes

N/A

Assignment

Describe:
Unit of randomisation (eg, individual, cluster, geographic).
Method used to generate the allocation schedule.
Method of allocation concealment and timing of assignment.
Method to separate the generator from the executor of assignment.

Yes

Yes

Yes

Yes

Masking (blinding)

Describe mechanism (eg, capsules, tablets); similarity of treatment characteristics (eg, appearance, taste); allocation schedule control (location of code during trial and when broken); and evidence for successful blinding among participants, person doing intervention, outcome assessors, and data analysts.

Yes

Heading

Subheading

Descriptor

Was it reported?

Page number

Results

Participant flow and follow-up

Provide a trial profile (figure) summarising participant flow, numbers and timing of randomisation assignment, interventions, and measurements for each randomised group.

 Yes

 21

Analysis

State estimated effect of intervention on primary and secondary outcome measures, including a point estimate and measure of precision (confidence interval).
State results in absolute numbers when feasible (eg, 10/20, not 50%).
Present summary data and appropriate descriptive and inferential statistics in sufficient detail to permit alternative analyses and replication.
Describe prognostic variables by treatment group and any attempt to adjust for them.
Describe protocol deviations from the study as planned, together with the reasons.

 Yes

 10,11

18-20

Comment

State specific interpretation of study findings, including sources of bias and imprecision (internal validity) and discussion of external validity, including appropriate quantitative measures when possible.
State general interpretation of the data in light of the totality of the available evidence

 Yes

 12-13