The section for specific liver event and laboratory test trigger definitions and follow-up requirements was updated to reflect the change that ALT or AST ≥ 3 × ULN should be the trigger for discontinuation of study treatment (changed from ALT or AST ≥ 5 × ULN). Other liver events and triggers made redundant due to this change were deleted.

Due to natural variation in blood eosinophils, inclusion criteria 7 (circulating eosinophils must be ≥ 300 cells/μL blood) was updated to add a three month window prior to the screening visit for the subject to meet the inclusion criteria. To facilitate the collection of blood eosinophil data prior to full screening, an optional pre-screen visit/hematology collection was added to the study design, scheduled from 3 months to the day prior to the screening visit. Exclusion criteria linked to safety was updated to require that they had to be met at both the screening and baseline visits, to align with the assessment schedule. The addition of a hematology sample on Day 21 allowed the stopping criteria related to white blood cells levels to be checked during the treatment period and for full interpretation of the ILC (innate lymphoid cell) data. Changes to the visit windows for each visit in the screening period were made to give greater flexibility to the site and subject for scheduling purposes, while maintaining the maximum screening window.