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The following evaluable patient populations are defined for selected endpoints: Tumor response will be evaluated in randomized patients with measurable disease at baseline, CA 19 9 response will be evaluated in randomized patients with available CA 19 9 assessment at baseline.
The effects of ground wave propagation on the vehicle guideway response will be evaluated in the numerical examples.
Posttreatment and potentially during treatment, patient response will be evaluated by blood analysis, usually without another biopsy, and molecular imaging to ensure the accurate differentiation of responders from non-responders.
Post-treatment and potentially during treatment, patient response will be evaluated by blood analysis, without another tumor biopsy, and molecular imaging to ensure the accurate differentiation of responders from non-responders.
Post-treatment and potentially during treatment, patient response will be evaluated by blood analysis and molecular imaging to ensure the accurate differentiation of responders from non-responders.
C-reactive protein, a measure of the inflammatory response, will be evaluated as a secondary outcome.
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FFQ responses will be evaluated by members of the research team who are unaware of the participants' identities.
Mother-infant stress responses will be evaluated by cortisol level assessment and autonomic function recordings (HRV, respiratory rate, body temperature).
In addition to safety as primary endpoint, the VXM01-specific immune reaction, as well as clinical response parameters will be evaluated.
Results, respectively response criteria will be evaluated in future.
At the end of 8 weeks of treatment, response status will be evaluated in all participating subjects.
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