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Trial eligibility change
| eligibility_criteria | Key Inclusion Criteria: 1. Adult patients with FOP who must have completed the double-blind treatment period of the parent study OPTIMA (R2477-FOP-2175 \[NCT05394116\]), as defined in the protocol 2. If the patient has progression of disease with Cumulative Analogue Joint Involvement Scale (CAJIS) \>19 at the time of EAP enrollment, the case will require discussion and evaluation between the treating physician and EAP Medical Director to determine final eligibility Key Exclusion Criteria: 1\. Patients participating in OPTIMA who are considered by the treating physician as inappropriate for this program for any reason NOTE: Other protocol defined inclusion / exclusion criteria apply | → | Key Inclusion Criteria: 1. Adult male and female patients with FOP, including patients who have completed the double-blind treatment period of the OPTIMA study (R2477-FOP-2175 \[NCT05394116\]). 2. If the patient has progression of disease with Cumulative Analogue Joint Involvement Scale (CAJIS) \>19 at the time of EAP enrollment, the case will require discussion and evaluation between the treating physician and EAP Medical Director to determine final eligibility Key Exclusion Criteria: 1\. Participants who participated in OPTIMA and are considered by the treating physician as inappropriate for this program for any reason NOTE: Other protocol defined inclusion / exclusion criteria apply |
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