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Pre-clinical research conducted primarily in animal models informs the hypotheses for its use, but no large randomized controlled trials in humans have confirmed efficacy for any outcome - including gut-lining support, tissue-related processes, or any other claimed mechanism

Services Provided by Lambda: Study design Clinical conduct Protocol development PK Sampling Safety lab evaluations Bioanalysis Pharmacokinetic and Biostatistical analysis CSR preparation and Report Compilation Study Execution Overview Sample Size: 60 healthy adult subjects (Male and Female) 60 healthy adult subjects (Male and Female) Study Duration & Visits ~5 weeks study duration, with multiple outpatient visits for PK sampling ~5 weeks study duration, with multiple outpatient visits for PK sampling Key Safety Measures Implemented (in addition to routine safety parameters) In addition to standard laboratory assessments at screening, specific safety parameters serum lipase and amylase were also evaluated

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The images were processed using the software FLIR ResearchIR MAX (4.40.12.38), and the mean temperature of brown adipose tissue area was represented

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