@ Steering Committee: TC to validate the final version of the protocol 14/10 at 12.00 CET

Please review the final version of PTC and especially the following topics:

Study design in synopsis:

  • Screening at week -2 ? cfr 6.3: "max 1 month before baseline"

  • SBP 160 AND/OR DBP>100

  • BMI>40= exclusion (up to 40=OK)

  • Visit 1 month, Visit 3 months, Visit 6 months, and Visit 9 months: liver tests by local lab if suspicion of liver disease/toxicity only

  • Lab parameters at B, 3,6,9,12: choose between 3 or 9 m

Protocol:

  • 4.1: HR: should be <100 bpm at screening/baseline, then as per guidelines during the study (but not cause to exclude patient during the study)

  • 6.3: Proposition to perform Central lab tests at 3 months instead of 9 months ? or keep at 9 months?

  • 6.4: Termination in case of non-compliance: less than 50% doses taken

  • 8.2: Liver function tests: mandatory at screening (local lab), then only to be repeated by local lab if suspicion of liver disease/toxicity (liver tests are included in Central lab measurements with biomarkers)

  • 8.2: SAE: SBP>180 AND/OR DBP >110 mmHg

  • 9.2.1: there is a proposition to use a different test for the statistical analysis of the 2 equally ranked primary endpoints

  • 9.2.2: HOMA: cfr final decision on this

Thank you in advance for your availability,

#SteeringCommittee

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