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Mason 2020)

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Current pharmacotherapy of heart failure with reduced ejection fraction (HFrEF) includes combination therapy with angiotensin-converting enzyme inhibitors (ACEi) and -adrenergic receptor blockers (-AR blockers), a therapy also used as treatment for non-cardiac conditions

Adult is not indicated for use in pediatric patients below the age of 11 years

The applicant reported that although the study is not complete, it has completed a planned interim analysis of the study that it believes directly addresses the previous lack of human outcomes data for the Axoguard HA+ Nerve Protector TM