Changes in version 0.5.1                        

Documentation

  - A vignette carries one task end to end on synthetic or bundled data,
    offline, and is built and run by R CMD check.
  - Runnable @examples added or corrected across 1 help pages. Each runs
    offline in seconds, writes nothing outside tempdir(), and is
    executed by R CMD check; anything needing a device, a download or an
    optional backend is fenced with the reason stated.

                        Changes in version 0.5.0                        

Power and sample-size for rehabilitation trial designs (R/power.R) — the
package could previously run and report a trial but not size or power
one.

  - sampleSizeContinuous() / powerContinuous() — two-arm continuous
    endpoint, cross-validated against base stats::power.t.test; adds
    unequal allocation, one/two-sided, dropout inflation, and cluster
    design effect.
  - sampleSizeANCOVA() — the recommended pre-post analysis,
    baseline-adjusted (variance x (1 - rho^2)); sampleSizeChangeScore()
    — change-from-baseline (SD x sqrt(2(1 - rho)));
    sampleSizeRepeatedMeasures() — mean of repeated post-baseline visits
    under compound symmetry (Frison & Pocock).
  - sampleSizeBinary() / powerBinary() — two-proportion / responder
    endpoint, matching stats::power.prop.test.
  - powerCurve() for planning; estimateBaselineCorrelation() estimates
    rho for ANCOVA planning from pilot vectors, a data frame, or a
    PhysioCohort.
  - All share cluster (ICC design effect) and dropout modifiers and
    return a printable trial_power object.

                        Changes in version 0.4.0                        

  - Adds deterministic, linked SDTM-shaped DM, AE, VS, EG, and
    sponsor-defined XP exports plus validated passthrough domains.
  - Adds ADaM-shaped ADSL and generic BDS exports preserving explicit
    analysis-set membership and exclusion metadata.
  - Adds structural validation and deterministic define.xml metadata
    stubs without claiming formal regulatory conformance.

                        Changes in version 0.3.0                        

  - Adds explicit ITT and per-protocol analysis sets with deterministic
    exclusion reasons.
  - Adds source-order-preserving outcome filtering, LOCF sensitivity
    handling, and explicit multiple-imputation callbacks.
  - Adds ANCOVA, delegated MMRM, and delegated MDC/MCID responder
    summaries.

                        Changes in version 0.2.0                        

  - Adds reconciled CONSORT participant-flow counts and optional
    DiagrammeR rendering.
  - Adds SPIRIT schedule-of-events tables and a SPIRIT 2013 checklist
    helper.
  - Adds typed adverse-event capture and AE/SAE summaries by arm,
    severity, and term.

                        Changes in version 0.1.0                        

  - Adds S4 models for trial arms, participants, randomized trials,
    concealed randomization sequences, and blinding management.
  - Supports simple, permuted-block, stratified-block, and Pocock-Simon
    minimization allocation with captured seeds and deterministic
    fingerprints.
  - Adds treatment-code management, append-only unblinding logs, and
    Bang blinding-index estimates.