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As will be documented below, a mass spectrometry experiment will provide evidence for this assertion.
The difference in GI and GL between the groups may also explain the possible BG variability in both groups as will be documented with (continuous glucose monitoring (CGM)).
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AS configurations, number, timing and reason for AS changes will be documented.
Pregnancy history, birth outcomes, as well as adverse events will be documented using a uniformed form.
Any additional clinical or laboratory investigations as well as unscheduled visits will be documented.
Patients with a negative laparoscopy will continue routine follow-up for at least 5 years from primary resection and during this period, oncological outcome in terms of local recurrence, metastases and survival as well as oncological therapies will be documented.
The number of patients not included in the study as well as reasons for exclusion will be documented.
The results of the colonoscopy as well as the histological confirmation of potential metachronous colorectal adenomas will be documented, as well as clinical data on medication, health status, complaints and adherence to capsule intake.
Absolute values will be documented as well as the T-score according to the DXA manufacturer's reference collective, e.g. -1.5 standard deviations (STD).
However, development of local complications will be documented as a secondary endpoint as will be the need for interventions.
SAE as demise, severe multiorgan failure, pulmonary hypertension, treatment unresponsive seizures will be documented as related to the primary illness itself.
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