............ 75 6.9 Baseline Parameters and Concomitant Medications ................................ .75 7 PROCEDURES AND QUALITY ASSURANCE ................................ ...................... 75 7.1 Procedures ................................ ................................ ................................ .75 7.1.1 Protocol amendments ................................ ................................ ................ 75 7.1.2 Monitoring ................................ ................................ ................................ .76 7.1.3 Data management ................................ ................................ ...................... 77 7.1.3.1 Data collection ................................ ................................ ........................... 77 7.1.4 Recording of data and retention of documents ................................ .......... 77 OSE2101 Protocol OSE2101C301 Confidential Version n°6.0 Page 22 of 101 02 February 2022 7.1.5 Audit ................................ ................................