Sample 80

NCT: NCT05888103 Model: local-qwen-0_5b RAG: no_rag
Deleted (in GT only) Added (in prediction only) Unchanged

Ground Truth

Inclusion Criteria:Written informed consent must be obtained before any assessment is performed.Fasting LDL-C of ≥ 130 mg/dL but < 190 mg/dLTriglycerides ≤ 400 mg/dLCategorized as low or moderate ASCVD risk by the 2016 Chinese GuidelineExclusion Criteria:Use of any LLT within 90 days prior to screening visitHistory of ASCVDDiabetes mellitus or fasting plasma glucose of ≥ 7.0 mmol/L or HbA1c ≥ 6.5%Secondary hypercholesterolemia, e.g.
hypothyroidism or nephrotic syndromeOther protocol-defined inclusion/exclusion criteria may apply.

Prediction

**Version Context:** This task is for the transition from ClinicalTrials.gov version 10 to version 11.
The evidence provided pertains to the inclusion and exclusion criteria for the study, specifically focusing on the eligibility criteria for participants.
Here is the revised version of the eligibility criteria:
---
### Original Eligibility Criteria (version 10):
#### Objectives and Endpoints
- **Primary goal**: Demonstrate the superiority of inclisiran as monotherapy, compared to placebo, in reducing LDL-C.
- **Secondary goals**:
- Demonstrate the efficacy of inclisiran as monotherapy, compared to placebo, in absolute change from baseline in LDL-C.
- Demonstrate the efficacy of inclisiran as monotherapy, compared to placebo, in percentage change from baseline in LDL-C.
- Demonstrate the efficacy of inclisiran as monotherapy, compared to placebo, in percentage and absolute change from baseline in PCSK9, TC, HDL-C, non-HDL-C, ApoB, ApoA-1, Lp(a) and TG at Day 150.
- Demonstrate the efficacy of inclisiran as monotherapy, compared to placebo, in absolute change from baseline in LDL-C at Day 150.
- Demonstrate the safety and tolerability of inclisiran as monotherapy compared to placebo during core part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- **Secondary endpoints**:
- Demonstrate the safety and tolerability of inclisiran as monotherapy during core part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension part.
- Demonstrate the safety and tolerability of inclisiran as monotherapy during extension
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