HIGHLIGHTS
- who: Unknown from the Data Collection and Management The data will be collected from paper case report forms (manually counter checked with source files by the data entry personnel) by the investigator and given to the statistician to analyze the dataThe data will be recorded by their specific ID number instead of participant`s name throughout the study unless otherwise specified. Access to data will be restricted to the investigators who signed the confidential disclosure agreement or to the institutional or governmental auditors during the study. All original documents and files will be archived for at least . . .
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