23 7.3.3. Analysis Software ................................ ................................ ................................ ......... 23 7.3.4. Study Data ................................ ................................ ................................ ..................... 23 7.4. Planned Study Analyses ................................ ................................ ................................ .................. 24 7.4.1. Statistical Summaries: Descriptive and Inferential ................................ ....................... 24 7.4.2. Interim Analyses and Data Monitoring ................................ ................................