HIGHLIGHTS
- who: Allan L. Reiss from the participants, and documentation evidencing the investigators` qualifications were submitted to the institutional review board at the Jaeb Center for Health Research with reciprocity at the IRB of each of the five participating clinical centers (Nemours Jacksonville, Stanford, Iowa, Washington University St Louis and Yale)The study was performed in accordance with ethical principles according to the Declaration of Helsinki (Fortaleza, October, ), seventh revision, th World Medical Association General Assembly Meeting and are consistent with the International Conference on Harmonization/good clinical practice, applicable regulatory requirements, and the sponsor or its delegate . . .
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