Systolic Blood Pressure Analysis

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Systolic blood pressure was analysed separately by BMI category in Studies B3P104833, B3A20005, and B3I105940. Additional variables were created within the combined datasets to create subset populations and categories for analysis.

3.2.3 Statistical Methodology
3.2.3.1 General Methodological Considerations
Subjects were included in all analyses if they received at least one dose of study medication. All data analyses were performed using SAS Version 9.2 and underwent double programming as part of the quality control process. Categorical data were summarized by the number and percent of subjects.
3.2.3.2 Maximum SBP Excursion Data Pooled Across Multiple Phase 1 Studies
The maximum post-baseline increase in systolic blood pressure for each

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