The following changes were implemented as per Amendment 1: 1. Update to include descriptive information on nonclinical findings relating to rat specific renal tubular degeneration to align with the investigator brochure (IB). 2. Update to clarify when study drug should be taken in relation to meal consumption and clarification regarding when treatment will start. 3. Update that subjects who terminate early from the study will have a final visit 30 days after their last dose of study drug. 4. Inclusion of stopping criteria for the study and for individual subjects based on Common Terminology Criteria for Adverse Events (CTCAE) grading. 5. Update to include surgeon’s documentation that laparoscopic ileocecal resection removed active disease. 6. Clarification to the use of concomitant medications: those excluded postoperatively and prior to study treatment, and those permitted for subject safety and well-being. 7. Inclusion of rescreening criteria. 8. Clarification that height will be measured during screening. 9. Clarification of patient reported outcomes (PRO) reporting requirements. 10. Clarification that local laboratory results should be entered into the electronic data capture (EDC). 11. Inclusion of urinalysis assessment as part of study procedures. 12. Clarification to accurately record dosing before PK sample collections. 13. Clarification of the purpose of RNA samples. 14. Inclusion of details on compliance measurement in case of a discrepancy. 15. Replacement of AE intensity terminology with the CTCAE Version 5 scale. 16. Clarification regarding the internal monitoring committee. 17. Clarification to the statistical analyses conducted for efficacy, pharmacodynamic analysis, PRO-2, interim analysis, and determination of sample size. 18. Updates to Appendix A, Schedule of Events, to align with clarifications within the text, including PRO-2 assessment on Day 1 and EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) assessment at screening.

Amendment 3 changes: 1. Addition of results from chronic toxicity studies in dogs and rats. 2. Updated information for phase 1b Study EBFIM117. 3. Changes to primary, safety, secondary, and exploratory objectives. 4. Change of primary endpoint and clarification of safety, secondary, and exploratory endpoints. 5. Updates and clarifications to overall study design based on longer duration of treatment that include addition of a stratification factor at randomization, changes to sample size, and addition of a Week 30. 6. Updated schematic of study design. 7. Addition of composition of study treatment tablets and their storage. 8. Addition of stratification of subjects by smoking status during randomization. 9. Clarifications to patient reported outcomes and to descriptions of patient-reported outcome 2 (PRO-2) and EQ 5D 5L instruments. 10. Updated time period for collection of concomitant medications and procedures. 10. Updated pregnancy testing requirements for longer treatment duration. 11. Addition of information regarding SAE reporting. 12. Corrections to statistical analyses sections. 13. Updates to Appendix A, Schedule of Events (and footnotes), to align with changes in text.

The following changes were implemented as per Amendment 4: 1. Specification that the surgical procedure is a prerequisite for enrollment to the study. 2. Specification of clinic visits on Day 1 (D1) and Week 26 (W26) and that study visits at screening and on W3, W6, W12, W18, and W30 may be conducted as clinic or HHC visits. 3. Clarification regarding study drug administration related to changes in study procedures related to the pandemic. 4. Clarification regarding physical examination (PE) during HHC visits. 5. Clarification regarding where PK sample collection times are recorded. 5. Addition of information regarding changes to study procedures due to the pandemic. 6. Clarification regarding posttreatment follow-up assessments for subjects who complete the study and for those who discontinue early. 7. Correction that the safety assessment does not include electrocardiogram changes from baseline.

The following changes were implemented as per Amendment 5: 1. Updates to the study signatories. 2. Addition of the International Nonproprietary Name (INN): sibofimloc.