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The rate of weight loss accelerates as doses escalate during the titration phase, with most clinical trial participants losing 5% to 10% of baseline body weight by week 12
doi: 10.1016/j.peptides.2021.170706 47 GallwitzBWittMFlschURCreutzfeldtWSchmidtWE
This violates the "Original" component of ALCOA and the explicit requirement of 211.68(b) that "A backup file of data entered into the computer or related system shall be maintained." The FDA considers the electronic stream from the instrument to be the raw data
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