- Create an hexagon sticker for the package.

Fix the calculation of intersection hypothesis pvalue when family weights is null for all gatekeeping procedures.

Revise the error fraction function to avoid floating point issue

Fix the images in the Case studies vignette

Revise the specification of serial and parallel parameters in MixtureGatekeepingAdj (matrix instead of list)

Revise the Outcome table generation function used for reporting

- As the
`ReporteRs`

R package is not available on the CRAN anymore, the report generation feature has been revised using the`officer`

and`flextable`

R packages. These packages are now required to use the`GenerateReport`

function.

Addition of the multinomial distribution (

`MultinomialDist`

, see Analysis model).Addition of the ordinal logistic regression test (

`OrdinalLogisticRegTest`

, see Analysis model).Addition of the Proportion statistic (

`PropStat`

, see Analysis model).Addition of the Fallback procedure (

`FallbackAdj`

, see Analysis model).Addition of a function to get the analysis results generated in the CSE using the

`AnalysisStack`

function (see Analysis stack).Addition of the

`ExtractAnalysisStack`

function to extract a specific set of results in an`AnalysisStack`

object (see Analysis stack).Creation of a vignette to describe the functions implementing the adjusted

*p*-values (`AdjustPvalues`

) and one-sided simultaneous confidence intervals (`AdjustCIs`

).Minor revisions of the generated report

It is now possible to use an option to specify the desirable direction of the treatment effect in a test, e.g.,

`larger = TRUE`

means that numerically larger values are expected in the second sample compared to the first sample and`larger = FALSE`

otherwise. This is an optional argument for all two-sample statistical tests to be included in the Test object. By default, if this argument is not specified, it is expected that a numerically larger value is expected in the second sample (i.e., by default`larger = TRUE`

).

Due to difficulties for several users to install the Mediana R package because of java issue, the

`ReporteRs`

R package is not required anymore (remove from Imports). However, to be able to generate the report, the user will require to have the`ReporteRs`

R package installed.Minor revision to the two-sample non-inferiority test for proportions to ensure that the number of successes is not greater than the sample size

Addition of the

`AdjustPvalues`

function which can be used to get adjusted p-values from a Multiple Testing Procedure. This function cannot be used within the CSE framework but it is an add-on function to compute adjusted p-values.Addition of the

`AdjustCIs`

function which can be used to get simultaneous confidence intervals from a Multiple Testing Procedure. This function cannot be used within the CSE framework but it is an add-on function to simultaneous confidence intervals.Creation of vignettes

- Revision of the dropout generation mechanism for time-to-event endpoints.

Addition of the Fixed-sequence procedure (

`FixedSeqAdj`

, see Analysis model).Addition of the Cox method to calculate the HR, effect size and ratio of effect size for time-to-event endpoint. This can be accomplished by setting the

`method`

argument in the parameter list to set-up the calculation based on the Cox method. (`par = parameters(method = "Cox"`

), see Analysis model).Addition of the package version information in the report.

Revision of one-sided p-value computation for Log-Rank test.

Revision of the call for Statistic in the core function (not visible).

Revision of the function to calculate the Hazard Ratio Statistic (HazardRatioStat method). By default, this calculation is now based on the log-rank statistic ((O2/E2)/(O1/E1) where O and E are Observed and Expected event in sample 2 and sample 1. A parameter can be added using the

`method`

argument in the parameter list to set-up the calculation based on the Cox method (`par = parameters(method = "Cox"`

), see Analysis model).Revision of the function to calculate the effect size for time-to-event endpoint (

`EffectSizeEventStat`

method, based on the`HazardRatioStat`

method)Revision of the functions to calculate the ratio of effect size for continuous (

`RatioEffectSizeContStat`

method), binary (`RatioEffectSizePropStat`

method) and event (`RatioEffectSizeEventStat method`

) endpoint.Revision of the function to generate the Test, Statistic, Design and result tables in the report.

Addition of the Beta distribution (

`BetaDist`

, see Data model).Addition of the Truncated exponential distribution, which could be used as enrollment distribution (

`TruncatedExpoDist`

, see Data model).Addition of the Non-inferiority test for proportion (

`PropTestNI`

, see Analysis model).Addition of the mixture-based gatekeeping procedure (

`MixtureGatekeepingAdj`

see Analysis model).Addition of a function to get the data generated in the CSE using the

`DataStack`

function (see Data stack).Addition of a function to extract a specific set of data in a

`DataStack`

object (see Data stack).Addition of the “Evaluation Model” section in the generated report describing the criteria and their parameters (see Simulation report).

Revision of the generation of dropout time.

Correction of the

`NormalParamAdj`

function.Correction of the

`FisherTest`

function.