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Ethics approval was submitted for the study in Japan; approval was granted November 2013.
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Seizure descriptions for the first three patients screened by each study site were submitted for the Epilepsy Study Consortium review in order to verify seizure classification; review of information for additional patients was required if initial classifications were incorrect.
The applications of the stacked events contained no studies with the GMPs in question and cited the studies submitted for the respective single-event IR maize application described above.
German cancer registries covering 13 of 16 federal states and 1 administrative region submitted data for the study.
On collection, the formalin-fixed and paraffin-embedded tissues were divided into three parts: the first to be submitted for conventional histological study; the second assayed for estrogen and progesterone receptors; the third used in molecular biology assays.
A part of each tissue of uterine cervical cancers was obtained immediately after hysterectomy and was snap-frozen in liquid nitrogen to determine the levels of VEGF-C, and a neighbouring part of the tissues was submitted for histopathological study.
A part of each tissue of uterine cervical cancers was snap-frozen in liquid nitrogen to determine IP-10, IL-8, and VEGF and a neighbouring part of the tissues was submitted for histopathological study including immunohistochemical staining for IP-10.
Approximately one-third of the equivocal lesions submitted for biopsy in the study were accurately identified as negative by the device and thus would not have needed a biopsy.
PCPs rarely used the clinic drop boxes to submit patients for the study.
The authors would like to acknowledge Betina Andersen, Lisbet Kioerboe and Hanne H. Moeller, for excellent technical assistance and Danish Crown Esbjerg, Holstebro, Ringsted, Skive, Skærbæk, Sønderborg and Vojens, Denmark for submitting organs for the study.
Samples from patients were submitted for diagnostic purposes (3 ); samples from carriers were submitted for epidemiologic studies (20 ).
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