Table 2 CONSORT recommendations in the protocol – Checklist for non-inferiority and equivalence trials. Items 1 through 12[17]

TITLE & ABSTRACT

1

How participants were allocated to interventions (e.g., "random allocation", "randomized", or "randomly assigned"), specifying that the trial is a non-inferiority or equivalence trial.

Title in cover page. Summary: section 1

INTRODUCTION Background

2

Scientific background and explanation of rationale, including the rationale for using a non-inferiority or equivalence design.

2 and 3. In particular, see 2.1.5, two last paragraphs for rationale for non-inferiority

METHODS Participants

3

Eligibility criteria for participants (detailing whether participants in the non-inferiority or equivalence trial are similar to those in any trial(s) that established efficacy of the reference treatment) and the settings and locations where the data were collected.

4.3 and 4.4.3

Interventions

4

Precise details of the interventions intended for each group detailing whether the reference treatment in the non-inferiority or equivalence trial is identical (or very similar) to that in any trial(s) that established efficacy, and how and when they were actually administered.

4.1

Objectives

5

Specific objectives and hypotheses, including the hypothesis concerning non-inferiority or equivalence.

3

Outcomes

6

Clearly defined primary and secondary outcome measures detailing whether the outcomes in the non-inferiority or equivalence trial are identical (or very similar) to those in any trial(s) that established efficacy of the reference treatment and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors).

4.2

Sample size

7

How sample size was determined detailing whether it was calculated using a non-inferiority or equivalence criterion and specifying the margin of equivalence 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).

4.4.3

Randomization – Sequence generation

8

Method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking, stratification)

4.4.1

Randomization – Allocation concealment

9

Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.

4.4.2

Randomization – Implementation

10

Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.

4.4.2

Blinding (masking)

11

Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated.

4 (last sentence before 3.1)

Statistical methods

12

Statistical methods used to compare groups for primary outcome(s), specifying whether a one or two-sided confidence interval approach was used. Methods for additional analyses, such as subgroup analyses and adjusted analyses.

4.4.3 & 4.5