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There were no meaningful differences between treatment groups for spirometry measurements at screening.
To assess test-retest reliability (stability), we examined the strength of agreement between peak VO2 pretreatment measurements at screening and baseline (up to 21 d after screening); no post-randomization data were used.
To explore possible biases due to missing tumor measurements at screening, we applied several different assumptions regarding the true tumor diameter of the unknown tumors, revealing very stable parameter estimates (data not shown).
Blood measurements at screening included safety tests (Chem 20; Medpace Reference Laboratories, Cincinnati, OH, USA), thyroid-stimulating hormone, complete blood count, pregnancy test and fasting serum lipids: TGs, LDL-C, TC and HDL-C levels.
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Diagnosis of T2DM was based on the investigators' assessment of medical history and/or fasting glucose measurement at screening.
Subjects in the diabetes trial had an HbA1c measurement of 6.5%11.0%% at screening.
Other safety assessments included a physical examination and vital signs measurement at screening and week 6.
Physical examinations, including measurements of weight and height were conducted at screening.
Safety assessments included AEs, clinical laboratory measurements (chemistry, hematology, and urinalysis) measured at screening, baseline, weeks 4, 12, 16, 24, and at follow up, 12-lead electrocardiograms, vital signs, and physical examinations.
Tumor size measurements were available for 92% of the cancers detected at screening.
A comparison of tumor measurements found at screening and in the Haukeland University Hospital database of clinically detected cases is shown in Figure 2.
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