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Comment: TOBA-356

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At a minimum, the nominal timing variables required for the analysis are PCNOMDY, PCTPTREF, and PCELTM; these timing variables have been populated, but PCDTC is null. PCRFTDTC is populated with only the date of dose as the time was not recorded in a manner readily available electronically. Although not crucial for the analysis, PCTPT was recorded and therefore populated in this example.

In this example, the sponsor applicant chose to populate PCTPTNUM with a simple sequential sorting order; therefore, no timing information can be assumed from the data represented in this variable.

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