D. Off-Study Criteria 
a. The development of any grade 3 or 4 toxicity that is not easily correctable. 
It should be noted that the assessment of neurological toxicity ( Neurosensory, 
neuromotor, neurocortical, neurocerebellar, neuro-mood, neuro-headache, etc. as 
appears in Appendix G - Toxicity Criteria) relates to the relative changes from the 
pre-treatment neurological status. 
b. Upon request of the participating patient or the person with the power of attorney. 
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