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Because the same soils and the same raw materials were used to prepare the amendments, the data collected for the first set of samples were used as a reference for the entire study.
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Any amendments to the data set will be documented.
Following a protocol amendment, the interim data from the trial was recently revealed to be promising, with increased median progression-free survival and overall response rate in the PEGPH20 arm compared with the gemcitabine/nab-paclitaxel arm.
According to the Race Relations (Amendment) Act 2000, the data should have been collected by local authorities and acted on where it revealed inequality.
We requested the committee for an amendment to expand the data collection to other schools, and we obtained approval for this.
Subsequent ethics amendments were approved once the data collection instruments were developed.
Any proposed amendments that would affect the data view (such as a request for additional variables) or risk potential disclosure are brought to the IGRP, and project outcomes are requested for scrutiny by this panel before publication as a final safeguard.
Prior to an amendment, these data were collected in the IMPACT study until disease-related pain occurred.
YMK is the medical monitor for the study; he has led amendments of the protocol, reviewed the data, and led the development of the clinical study report.
Robustness was established by: summarising the key points of each interview to each participant and making any amendments they suggested; continually revisiting the data; and referring to field notenotes in the context of each participant's account.
During the data extraction process, some amendments were made to the original framework.
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