The following changes were made: 1. To reduce burden on patients, gluten stool sample collection was made optional except for the two samples collected at the time of the endoscopy and biopsy collection (Screening and Week 12 / Early Termination, which remain mandatory). 2. The rules for collection of stool samples were revised to allow a more flexible window of ±3 days and to allow any place of collection rather than the patient’s home only. 3. The time of collection of the blood cell pellet was changed to allow collection at any time during study. 4. The cut-off value of mucosal damage, under which subjects were excluded from the gluten challenge, was lowered from 2 to 1.8. Subjects with VH:CD of ≤ 1.8 were not allowed to receive gluten challenge, while subjects with VH:CD ≥ 1.9 could receive challenge. 5. The age limit was increased to 80 years old. 6. The cut-off criterion of symptoms at baseline was increased from a CeD-GSRS score of 2 to 2.3. 7. The following discretion was added to Inclusion Criterion 10: “…unless investigator considers the abnormalities to be not clinically significant.” 8. A note was added to indicate that the Sponsor could arrange with the study sites the conduct of some of the intermediate visits at the subject’s home, provided that appropriate healthcare personnel conducted the visit with similar standards to visits conducted at the study site. 9. A duplicated sentence on mini-gut experiments in biopsy fragments was removed and minor inconsistencies were corrected. 10. The procedure for retaining unused vials was clarified. 11. It was clarified that the alternation of side of the abdomen for the SC injections was between visits and not between the two injections in the same visit. 12. It was clarified that the DSMB could, and was expected to, review unblinded data. The safety findings insufficient to trigger the stopping rules could, if judged appropriate by the DSMB, lead to suspension of enrollment during review.

The following changes and clarifications were made: 1. Elimination of the stool test as an eligibility criterion, since endoscopy and biopsy already identified patients with gluten contamination, as revealed by mucosal atrophy. 2. Removal of the exclusion criterion for blood donation 3 months before study entry, initially meant to prevent anemia by avoiding administering gluten challenge to patients who had had a recent blood donation; the precaution was considered unnecessary and preventing otherwise eligible patients from enrolling in the study. Blood donation remained prohibited during the study. 3. Modest villous atrophy threshold was changed for patients not receiving the gluten challenge to avoid excluding a few candidates, which would otherwise be considered eligible for the study.