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Not all of the indicators listed here need to be included in ADSL. As stated in Section 2.9.6.4 Flag Variable Conventions, only those indicators corresponding to populations defined in the statistical analysis plan or populations used as a basis for analysis need be included in ADSL.

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The values of subject-level population flags cannot be blank. If a flag is used, the corresponding numeric version (*FN, where 0 = No and 1 = Yes) of the population flag can also be included. Please also refer to Section 2.9.6.4 Flag Variable Conventions.

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