Secondary Outcome(s)
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Annual Rate of Change in Weight
[Time Frame: Up to 3 years following randomization.]
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Annual Rate of Change in Height-for-age Z-score
[Time Frame: Up to 3 years following randomization.]
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Annual Rate of Change in the Absolute Diameter of the Aortic Annulus
[Time Frame: Up to 3 years following randomization.]
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Annual Rate of Change in the Absolute Diameter of the Ascending Aorta
[Time Frame: Up to 3 years following randomization.]
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Annual Rate of Change in Weight-for-height Z-score
[Time Frame: Up to 3 years following randomization.]
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Event Rate of Aortic Dissection.
[Time Frame: Up to 3 years following randomization.]
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Event Rate of Death
[Time Frame: Up to 3 years following randomization.]
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Event Rate of the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.
[Time Frame: Up to 3 years following randomization.]
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Annual Rate of Change in Aortic-annulus-diameter Z Score, Adjusted by Body-surface Area
[Time Frame: Up to 3 years following randomization.]
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Annual Rate of Change in Body Mass Index for Age Z-score
[Time Frame: Up to 3 years following randomization.]
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Annual Rate of Change in Weight-for-age Z-score
[Time Frame: Up to 3 years following randomization.]
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Annual Rate of Change in Arm Span to Height Ratio
[Time Frame: Up to 3 years following randomization.]
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Number of Participants With Aortic-root Surgery.
[Time Frame: Up to 3 years following randomization.]
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Number of Participants With the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.
[Time Frame: Up to 3 years following randomization.]
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Adverse Drug Reactions Reported at the Baseline Visit
[Time Frame: At baseline]
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Annual Rate of Change in Ascending-aorta-diameter Z Score, Adjusted by Body-surface-area.
[Time Frame: Up to 3 years following randomization.]
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Event Rate of Aortic-Root Surgery
[Time Frame: Up to 3 years following randomization.]
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Number of Death.
[Time Frame: Up to 3 years following randomization.]
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Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Absolute Dimension
[Time Frame: Up to 3 years following randomization.]
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Annual Rate of Change in Height
[Time Frame: Up to 3 years following randomization.]
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Annual Rate of Change in Total Aortic Proximal Regurgitant Jet Area Indexed to Body-surface-area
[Time Frame: Up to 3 years following randomization.]
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Number of Participants With Aortic Dissection.
[Time Frame: Up to 3 years following randomization.]
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Adverse Drug Reactions Reported During Routine Follow-up Surveillance
[Time Frame: From 6 months to 3 years following randomization.]
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Annual Rate of Change in Body Mass Index
[Time Frame: Up to 3 years following randomization.]
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Annual Rate of Change in Upper to Lower Segment Ratio
[Time Frame: Up to 3 years following randomization.]
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