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Weight loss: Until goals are met, with a maintenance plan

Top Inspectional Observations (from FDA Form 483s): Clinical Investigators: Failure to follow investigational plans and Form FDA 1572 requirements Inadequate case history records and safety reporting Inadequate accountability and/or control of the investigational product Informed consent deficiencies (Consistent with cases involving protocol deviation and missing legal guardian consent) IRBs: Inadequate documentation of meetings, voting, and quorum Failure to conduct initial and/or continuing review of research Failure to keep members of the IRB advised of research proposals that have been approved under an expedited review procedure Failure to follow FDA regulations regarding expedited review procedures Missing compensation disclosures and FDA inspection statements in ICFs (Echoed in recent IRB Warning Letters with repeat observations over decades) Sponsors and CROs: Failure to properly monitor investigations Failure to meet the abbreviated requirements for investigational device exemptions (IDEs) Failure to maintain and/or retain adequate records in accordance with 21 CFR 312.57

The NAS is a histological scoring system for MASH, ranging from 0 to 8, with scores 5 and greater correlating highly with MASH [41]

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Some people count slowly to ten as they push the plunger