Part B Secondary Endpoints Sample Clauses

Part B Secondary Endpoints. CORE Study:  Change in sweat chloride from Baseline to all post-baseline visits  Change in BMI and body weight from Baseline to all post-baseline visits  Change in sputum microbiome and markers of inflammation from Baseline to selected post-baseline visits. Other Evaluations for all Sub-Studies:  The core and sub-studies will be linked so that associations between primary and secondary endpoints from each sub-study and clinical parameters (e.g., spirometry, weight, and sweat chloride) may be explored. GIFT Sub-Study  Glucose/Insulin Functional Testing: o Percent in each OGTT category (Section 8.1.4) at each visit, and change in category from Baseline to all subsequent visits o HbA1c at each Visit and change from Baseline to all subsequent visits o For subjects on insulin therapy, insulin dose (units/kg/day) at each visit, and change in dose from Baseline to all subsequent visits.  Gastro-intestinal Functional Testing Sub-Study: o Percent with positive breath test by Fridge Criteria at Baseline and Visit 5 o Mean fasting hydrogen levels (ppm) at Baseline and Visit 5 and change from Baseline to Visit 5 among those with measures at both time points (i.e., positive breath test at Baseline). pH-Pill Sub-Study  Change in the small intestinal pH during the initial 120 minutes of small bowel transit, post gastric emptying  Change in time to reach and sustain intestinal pH above 5.5 from Baseline to Visit 5  Change in the functional model of the pH curve from Baseline to Visit 5. MBW/FENO Sub-Study  Change in LCI from Baseline to all subsequent visits  Percentage of subjects producing research quality measurements at all visits  Change in FENO from Baseline to all subsequent visits. MCC Sub-Study: The following changes will be examined between Baseline and Visit 5:  Change in average whole lung clearance between 0 and 30 minutes (AUC30) and between 0 and 90 minutes (AUC90)  Change in AUC60 in the peripheral lung compartment  Change in AUC60 in the central lung compartment  Change in cough clearance (average clearance measured between 60 – 90 minutes after isotope inhalation)  Change in whole lung clearance measured through 24 hours.
Sample 1
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Related to Part B Secondary Endpoints

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