1.1 Introduction 1

1.2 Continuous Endpoints 3

1.3 Categorical Endpoints 19

1.4 Time-to-Event Endpoints 40

1.5 Tests for Qualitative Interactions 56

2.1 Introduction 67

2.2 Single-Step Tests 70

2.3 Closed Testing Methods 74

2.4 Fixed-Sequence Testing Methods 84

2.5 Resampling-Based Testing Methods 89

2.6 Testing Procedures for Multiple Endpoints 94

2.7 Gatekeeping Strategies 104

3.1 Introduction 129

3.2 Reference Intervals for Safety and Diagnostic Measures 130

3.3 Analysis of Shift Tables 157

4.1 Introduction 177

4.2 Repeated Significance Tests 181

4.3 Stochastic Curtailment Tests 235

5.1 Introduction 269

5.2 Case Studies 271

5.3 Data Setting and Modeling Framework 273

5.4 Analysis of Complete Growth Data 276

5.5 Simple Methods and MCAR 287

5.6 Available Case Methods 300

5.7 Likelihood-Based Ignorable Analyses 301

5.8 Multiple Imputation 308

5.9 The EM Algorithm 326

5.10 Categorical Data 332

5.11 MNAR and Sensitivity Analysis 353

5.12 Summary 354