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Clinical Review Report: Sapropterin dihydrochloride (Kuvan) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2017 Sep.

Cover of Clinical Review Report: Sapropterin dihydrochloride (Kuvan)

Clinical Review Report: Sapropterin dihydrochloride (Kuvan) [Internet].

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Abbreviations

ACMG

American College of Medical Genetics and Genomics

ADHD

attention-deficit/hyperactivity disorder

ADHD-RS

Attention Deficit Hyperactivity Disorder Rating Scale

ANCOVA

analysis of covariance

ASRS

Adult Attention Deficit Hyperactivity Disorder Self-Report Scale

AE

adverse event

BL

baseline

BMI

body mass index

BRI

Behavioral Regulation Index

BRIEF

Behavior Rating Inventory of Executive Function

CMH

Cochran—Mantel—Haenszel

CGI-I

Clinical Global Impression—Improvement

CGI-S

Clinical Global Impression—Severity

CI

confidence interval

DB

double-blind

GEC

Global Executive Composite

EAP

Exceptional Access Program

HAM-A

Hamilton Anxiety Rating Scale

HAM-D

Hamilton Depression Rating Scale

HPA

hyperphenylalaninemia

IQ

intelligence quotient

ITT

intention-to-treat population

IVRS

interactive voice response system

LOCF

last observation carried forward

MI

Metacognition Index

NA

not applicable

NR

not reported

OL

open-label

PC

placebo-controlled

PG

parallel-group

Phe

phenylalanine

PKU

phenylketonuria

PO

by mouth

PP

per-protocol

RCT

randomized controlled trial

RR

relative risk

SAE

serious adverse event

SAP

sapropterin

SD

standard deviation

SDS

standard deviation score

SE

standard error

WDAE

withdrawal due to adverse event

Copyright © 2017 Canadian Agency for Drugs and Technologies in Health.

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Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK533811
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