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Abstract:
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In recent years, long term outcome phase 3 studies have often been required for new drug application in chronic treatment in therapeutic areas such as cardiovascular and diabetes. In such long term studies, lost patient follow up due to withdrew consent or other reasons is an inevitable reality, especially when the outcome measures require in-patient visit. Besides planning and implementing study execution accordingly to minimize the lost follow up, statistical analysis approaches must also be thoughtfully planned to account for the resulted missing data and provide the valid inference. A few analysis approaches will be proposed and discussed.
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