Additional management included dose modification of study drugs.
JAS was responsible for study concept and design, modification of study design, review and interpretation of analyses, drafting of the manuscript and made revisions to the manuscript.
Other secondary outcomes were IFI- and IA-related mortality, all-cause mortality and adverse events leading to discontinuation or modification of study drug.
Concurrent medication and modification of study treatment (i.e., temporary interruption and/or dose reduction) were commonly used to manage ALT and AST elevations.
Thus, the effect modification of study location we observed may reflect the differences in dietary pattern in relation to diabetes risk between Eastern and Western population.
The authors declare that they have no competing interests AG, PFr, GP, GV, and BG were responsible for study concept and design, modification of study design, and review and interpretation of data.
The most common AEs, reported in three or more patients, are shown in Table 2. Gastrointestinal AEs and fatigue were generally mild to moderate (CTCAE grade 1 2), intermittent and manageable on continued treatment, requiring no modification of study treatment.
Of note, this modification may simply be a surrogate of effect modification of study location because all studies with a follow-up period (mean ∼16 years) above the average study duration (∼11 years) were conducted in Western countries, whereas most studies with a follow-up period (mean ∼8 years) below the average study duration were conducted in Asia.
On the electronic eCRF, there should only be recorded: serious adverse drug events; adverse events of any grade related to the study medication, in the opinion of the PI; adverse events of any grade leading to modification of study drug dosage, its interruption/early discontinuation.
