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Protocol Document

4.1 Inclusion Criteria

Subjects who meet all of the following criteria are eligible for enrollment:

Male or female subjects aged 18 to 80 years (inclusive) at the time of informed consent.
LDL-C ≥70 mg/dL (1.8 mmol/L) despite stable statin therapy at maximally tolerated dose for ≥4 weeks prior to screening.

4.2 Exclusion Criteria

Subjects who meet any of the following criteria are not eligible:

Acute coronary syndrome (ACS), stroke, or transient ischemic attack (TIA) within 3 months prior to screening.
Uncontrolled hypertension, defined as systolic BP >180 mmHg or diastolic BP >110 mmHg at screening.

Generated CRF Form

1. Does the subject meet the age criterion (18-80 years)?Ref: Sec. 4.1.1

Yes

2. Does the subject have LDL-C ≥70 mg/dL despite stable statin therapy?Ref: Sec. 4.1.2

Yes

1. Has the subject experienced ACS, stroke, or TIA within 3 months?Ref: Sec. 4.2.1

Yes

2. Does the subject have uncontrolled hypertension?Ref: Sec. 4.2.2

Yes

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