Sample 35

NCT: NCT06149104 Model: local-gemma2-9b RAG: no_rag
Deleted (in GT only) Added (in prediction only) Unchanged

Ground Truth

Inclusion Criteria:Signed informed consent<18 years of age (at the time of signing informed consent)Completed CLCZ696B2319E1 study and safely enrolledExclusion Criteria:Permanently discontinued the study treatment during CLCZ696B2319E1 studyRenal vascular hypertension (including renal artery stenosis)History of angioedemaHaving parents or legal guardians who do not give consent or allow the child to give assent, or inability of patient or the parents/legal guardians to follow instructions or comply with follow-up proceduresAny medical condition(s) that may put the patient at risk in the Investigator's opinion or that the Investigator deems unsuitable for the study

Prediction

## Amended Eligibility Criteria (Version 6)
**Inclusion Criteria:**
* Signed informed consent and assent (if applicable) obtained prior to participation in the study.
* Male or female, inpatient or outpatient, and aged ≥ 1 year.
* Completed the PANORAMA-HF OLE study (CLCZ696B2319E1) and safely enrolled.
* Systolic blood pressure (SBP) ≥ the calculated 5th percentile SBP for age as described in Appendix 7.
* No conditions that preclude continuation according to the Investigator’s judgment, including hypotension.
**Exclusion Criteria:**
* Permanently discontinued the study treatment during the PANORAMA-HF OLE study.
* Renal vascular hypertension (including renal artery stenosis).
* History of angioedema.
* Parents or legal guardians who do not give consent or allow the child to give assent, or inability of the patient or the parents/legal guardians to follow instructions or comply with follow-up procedures.
* Any medical condition(s) that may put the patient at risk in the Investigator’s opinion or that the Investigator deems unsuitable for the study.