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)

CONSORT criteria	Included in present evaluation	Category	Description of assessed variables
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	-	-