I it is more of your choice No 1 than 2. You may see differences between trials in which systemic drugs and dosing schedules are allowed or not and also in radiation schedules plus thresholds for 'evaluable' subjects, but that tends to be it. BTW: Some (protocol) elements were added due to the criticism of Kepivance HNC trials - stratification for HPV, for instance.
Water for injection: sterile, filtered or distilled water.
Why only 3 mg/mL concentration? It is possible that 3 mg/mL concentration comes as 'inheritance' from Polymedix - they tested Brilacidin against SOM in mice and found concentrations 1 mg/mL, 3 mg/mL and 10 mg/mL effective with not much efficacy difference in between them. I have not seen reports about safety or side effects. That's as far as my knowledge goes.
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