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Authors
Merikle, Elizabeth
Tich, Nancy
Sebree, Terri
Hagerman, Randi
O’Quinn, Stephen
Nomikos, George
Bzdek, Kristen
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Funding
Funding for this research was provided by:
Harmony Biosciences (Harmony Biosciences)
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Article History
Received: 28 July 2025
Accepted: 23 March 2026
First Online: 1 April 2026
Declarations
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: This study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and was approved by Advarra, Inc. Institutional Review Board (IRB; Approval Number: Pro00037386). Concept Elicitation Interviews: Caregivers provided written informed consent for the interviews to be recorded for data collection purposes. Caregiver Survey: The protocol for the study (CONNECT-FX) was approved by the individual institution Investigational Review Boards (IRBs) and Ethics Committees or by the central IRB, WCG IRB. Cognitive Interviews: The protocol for the cognitive interview study was approved by the central IRB, Advarra.
: All authors have reviewed the manuscript and approved it for publication.
: EM was an employee of Fortrea, Inc. at the time of the study, which received funding from Harmony Biosciences for this research. EM, NT, KB and GN are employees of Harmony Biosciences. RH has received funding from Zynerba Pharmaceuticals/Harmony Biosciences and Tetra/Shionogi Pharma to carry out clinical trials in Fragile X syndrome. TS and SOQ are paid consultants for Harmony Biosciences.
