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This document contains detailed information regarding study OBJECTIVES and statistical methods to aid in the production of the CLINICAL Study Report (CSR) including summary tables, figures, and subject data LISTINGS for Protocol. This document also contains documentation of the program variables and algorithms that will be used to generate summary statistics and statistical analysis.

This document contains detailed information regarding study objectives and statistical methods to aid in the production of the Clinical Study Report (CSR) including summary tables, figures, and subject data listings for Protocol. This document also contains documentation of the program variables and algorithms that will be used to generate summary statistics and statistical analysis.



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