Data collection and handling
MEDOCS, CRF
ADVERSE EVENTS, CRF
For data collection, the newest version of SPSS (currently Version 26) will be used.The results from the medical history and the physical examination are entered in the CRF. In addition, we will document the visit progress and whether every test and procedure was completed according to the protocol. This includes the laboratory codes used to identify the lab results, the intervention code from the sachets (or the allocation to metformin), as well as any adverse events.For monitoring purposes, data from the paper CRF will be entered into an online CRF available at the Phoenix database of the Medical University of Graz.The lab results from the study will be measured at the Endocrinology Lab Platform and the Clinical Institute of Medical and Chemical Laboratory Diagnostics and entered into the hospital patient information program “MEDOCS”, with the study-specific code attached to the data. From there, all results from the study can be downloaded in an excel sheet using the study code. Only authorized personnel have access to MEDOCS and only study-related personnel may access the study-specific results. All collected data will then be transferred to SAS for further analysis.