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TABLE: Study sites where patients were screened and consent was obtained, and relevant independent ethics committee or institutional review boards responsible for approving the study protocol

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TABLE: Study sites where patients were screened and consent was obtained, and relevant independent ethics committee or institutional review boards responsible for approving the study protocol

Study site number

Institution where study conducted IEC or IRB address

9001 Rady Children's Hospital San Diego 3020 Children's Way

San Diego, CA 92123 United States

University of California San Diego Human Research Protections Program

9500 Gilman Dr, Mail Code 0052 La Jolla, CA 92093-0052

United States 9004* University of Southern California MCA

Clinic

2010 Zonal Ave, Medical Village, OPD 5 W Los Angeles, CA 90033

United States

University of Southern California Health Sciences Institutional Review Board (HSIRB)

1200 N. State St, General Hospital, Ste 4700

Los Angeles, CA 90033 United States

9043 Szabolcs-Szatmár-Bereg County Hospitals and University Teaching Hospital

68 St. Stephen’s Street Nyiregyhaza, 4400 Hungary

Scientific Committee on Clinical Pharmacology Ethics

7-8 Stephen Szechenyi Square Budapest, 1051

Hungary

9045 St. Stephen and St. Ladislaus Hospital- Clinic

5-7 Albert Florian Street Budapest, 1097

Hungary

Scientific Committee on Clinical Pharmacology Ethics

7-8 Stephen Szechenyi Square Budapest, 1051

Hungary 9046 St. John’s Hospital and United Hospitals

of North-Buda

Buda Children’s Hospital 1-3 Diosarok Street Budapest, 1125 Hungary

Scientific Committee on Clinical Pharmacology Ethics

7-8 Stephen Szechenyi Square Budapest, 1051

Hungary

*One patient was screened and had consent obtained to participate in the study; however, during the site close-out visit, after database lock, this patient was discovered to be a screen failure, and was not enrolled. No other patients were enrolled at this site.

IEC, independent ethics committee; IRB, institutional review board.

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