The planned study population with inclusion/exclusion criteria is clearly described.
The planned interventions and their timing are described.
The primary and secondary outcome measures are described, as well as how the target sample size was projected.
The rationale and methods for statistical analyses, as well as whether or not intention-to-treat analysis was performed, are described.
Early stopping rules are prospectively defined.
Stratification utilizing appropriate known prognostic variables is performed.
The trial profile summarizing participant flow, numbers and timing of randomization assignment, interventions, and measurements for each randomized group is provided.
The estimated effect of intervention on primary and secondary outcome measures including a point estimate and measure of precision (confidence interval) is stated, and results are given in absolute numbers when feasible.
The summary data and appropriate descriptive and inferential statistics are provided in sufficient detail to permit alternative analyses and replication.
The protocol deviations of the study plan are described, together with reasons.
The specific interpretation of study findings is stated, including sources of bias and imprecision (internal validity) and external validity, including appropriate quantitative measures when possible.
A general interpretation of the data in light of the totality of the available evidence is presented.
The follow-up of patients who have not failed is described.
