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Aseptic Preparation and Storage: Principles for Clinical Trial Settings Reconstitution of injectable investigational products must be performed by trained personnel following the trial protocol, using the specified diluent, in an appropriate aseptic environment

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Depending on the patient, monitoring may include: Weight trends Waist circumference Blood pressure Glucose and A1C Lipids Liver markers Kidney markers Thyroid markers when appropriate Nutrient markers when indicated Hormone considerations when relevant Adjust the Plan as the Body Changes A patients needs at the start of treatment may not be the same after losing 20, 40, or 60 pounds