No subject in either group had history or clinical or laboratory signs of systemic inflammatory disease.
No subject from either group showed visible abnormalities on T1-weighted structural images.
No subject in either group reported gastrointestinal symptoms during the solicited follow-up period.
None of these hypoglycemic episodes was considered severe, and no subject in either group discontinued due to hypoglycemia.
No subject in either group had an increase in aspartate or alanine aminotransferase level to >3 times ULN with an increase in bilirubin level >2 times ULN.
No subject in either E group had a ΔQTcF exceeding 30 ms and only one subject in the E 84 mg group had a single QTcF >450 ms at 16 hours.
No subjects in either group had a history of smoking or contraindications for MR scanning.
No subjects in either of the treatment groups reported episodes of severe hypoglycemia.
No subjects in either group developed a surgical site infection and only one subject (in the Treatment group) developed a post-operative wound infection.
There was no overlap of subjects (either H-ESKD cases or controls) between this study and the study described in the companion publication; however, the phenotype definition for H-ESKD between the two studies was nearly identical (12).
