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Finally, it should make an adequate assessment of the proposed project and should suggest design modifications, in the event that only part of the project can be sanctioned.
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Criteria for dose modification in the event of toxicity have been described previously (Reni et al, 2004b).
In phase II of the study, the dose administered was the MTD as defined in phase I, subject to dose modification in the event of toxicity as described below.
Protocol dose modifications were permitted in the event of predefined toxic effects related to chemotherapy or cetuximab [ 17].
We also observed a similar pattern of ORF change or domain modification in the AS events with different isoform ratios.
Dose modification was carried out in the event of haematological or other toxicities as defined by the NCIC CTG Expanded Common Toxicity Criteria.
Recent changes or recombinational events also have been seen in the ctx gene cluster, with introduction of the classical biotype ctx gene into an El Tor background and the appearance of strains containing multiple recombinational events that have modifications in ctx as well as other changes that result in loss of traditional El Tor biotype characteristics (10, 11, 27 ).
The extent by which E-cadherin transcription is up-regulated by prostasin re-expression could be impacted by epigenetic modifications in the E-cadherin promoter, events that are common in cancer cells [ 24, 25].
Treatment modifications are commonly only made in the event of on-treatment problems such as significant weight loss or mask fitting problems.
Dose modification and delay was permitted in the event of some treatment-related side effects.
In patients with an initially normal infrahissian conduction time on the electrophysiological study, the risk of complete AVB is very low, and a second electrophysiological study should be performed only in the event of modifications in atrioventricular conduction ECG parameters or SA-ECG in annual check-ups.
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