| 2022-04-26 | 2.0 Revision Draft | - Converted the supplement to the current WIKI QRS supplement template
- Updated the title by adding the QSCAT value at the end (e.g., EXACT) and matching the full title stated in the user manual
- Annotated CRF updated to the MSG V2.0 annotation guidelines
- Added assumption 2 on using the QSEVINTX variable and added it to the example
- Added assumption 3 on the inclusion of 4 respiratory symptom raw and domain scores, a raw EXACT total, and an EXACT total score as described in the user manual
- Added assumption 4 to describe how QRS planned diary data aligns with the QS domain timing variables
- Added assumption 5 regarding the need for a record of each day of the study. The example was updated with a diary day having no responses.
- The QSEVAL assumption and variable was removed from this supplement because it is not captured on the CRF and no assumptions are made on the potential values.
- Updated the example to represent all 7 diary days related to VISITNUM = 1 to indicate that dairy days are planned observations with the QSDTC dates represented
- Revised the QSSTRESC and QSSTRESN values in the example and section 4 to values of "xxx" to represent numeric values based on the user manual description of how these numeric values are represented
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