TABLE 1.

Items that should be addressed in a statistical analysis plan for a human nutrition RCT¹

Section and Item
Section 1: Administrative information
Title and clinical trial registration number
Analysis plan version, including revisions
Roles and responsibilities of key personnel
Section 2: Introduction
Background and rationale for the trial
Study objectives
Section 3: Study methods
Trial design
Randomization/allocation concealment/blinding procedures
Sample size justification/calculations
Framework for hypothesis testing (e.g., superiority, non-inferiority,equivalence)
Planned interim analyses and stopping rules, if applicable
Timing of outcome assessments and analysis
Section 4: Trial population
Screening data and eligibility criteria
Recruitment
Early withdrawal of participants
Presentation of baseline characteristics
Section 5: Analysis population(s)
Analysis populations (e.g., intention-to-treat, per protocol, completers,safety)
Adherence/compliance and protocol deviations/violations
Section 6: Hypothesis testing
Multiple hypothesis tests (multiplicity)
Number of groups or conditions
Number of outcome variables evaluated
Composite outcome variables
Section 7: Statistical analysis
Outcome variable definitions
Accounting for covariates
Repeated measurements
Missing data
Additional planned analyses (e.g., sensitivity, subgroup, exploratoryanalyses)
Safety and tolerability analyses
Data presentation
Statistical software

¹RCT, randomized controlled trial.