Table 1 Description of the assessment of CONSORT criteria recommended in the extension to CONSORT for non-inferiority and equivalence trials [11] (R = reporting item, M = methodological item, I = interpretation)

Specify that the trial is a non-inferiority or equivalence trial

Yes

R

Clearly identified as non-inferiority or equivalence trial in title, abstract or full paper

Rationale for using a non-inferiority or equivalence design

Yes

R

Justification stated for using a non-inferiority or equivalence design

Eligibility for participants with respect to trials that established efficacy of the reference treatment

No

-

-

Interventions intended for each group with respect to trials that established efficacy of the reference treatment

No

-

-

Specific objectives and hypothesis concerning non-inferiority or equivalence

Yes

R

Hypothesis stated clearly (text or formula)

M

Margin defined

Clearly defined primary and secondary outcome measures with respect to trials that established efficacy of the reference treatment

(Yes)

R

Primary outcome identified clearly (not evaluated whether outcome is identical to those in any trial that established efficacy of the reference treatment)

Sample size calculation using a non-inferiority or equivalence criterion and specifying the margin with the rationale for its choice. When applicable, explanation of any interim analyses and stopping rules (and whether related to a non-inferiority or equivalence hypothesis)

Yes

R

Sample size calculation presented

R

Elements for recalculation of sample size reported

M

Margin considered

R

Justification for margin stated

R

Interim analyses planned

Method used to generate random allocation sequence including details of any restriction

Yes

R

Method of randomisation reported

R

Restriction method reported (blocking/stratification/minimisation)

Method used to implement allocation concealment

No

-

-

Who generated the allocation sequence and enrolled and assigned participants

No

-

-

Whether participants, those administering the interventions and those assessing the outcome were blinded to group allocation

Yes

R

Method of blinding reported (any blinding; single blind, double blind, open or double dummy design)

Statistical methods used to compare groups for primary outcome specifying whether a 1- or 2-sided confidence interval approach was used. Methods for additional analyses (subgroups, adjusted analyses)

Yes

R

Statistical methods used for comparison reported

Participant flow through each state of the trial (diagram strongly recommended)

Yes

R

Diagram of flow of participants presented

Dates defining the periods of recruitment and follow-up

Yes

R

Dates reported

Baseline information for each group

Yes

R

Baseline information presented for each group

Number of participants in each group included for each analysis and whether intention-to-treat (ITT) and/or alternative analyses were conducted

Yes

R

Number of participants reported - similar to 13

R

Analysis sets reported

M

Results of ITT and per-protocol analysis presented

For each outcome, a summary of results for each group and the estimated effect size and its precision (useful: figure showing confidence intervals and margins)

Yes

M

Results presented using a confidence interval

R

Report of confidence level and 1- or 2-sided

R

Report of P-value

R

Figure presented

Address multiplicity by reporting any other analyses performed

No

-

-

All important adverse events or side effects in each group

Yes

R

Adverse events reported

Interpretation of the results taking into account the non-inferiority or equivalence hypothesis, sources of potential bias or imprecision

Yes

I

Interpretation of results presented

Interpretation correct (non-inferiority/equivalence/superiority/inferiority/inconclusive result/wrong/incomprehensible by means of presented results)

Statement on expected advantage

Generalisability (external validity) of the trial findings

No

-

-

General interpretation of the results in the context of current evidence

No

-

-