There's no need for sugar pills or placebos. If you're asking...

There's no need for sugar pills or placebos. If you're asking about a future randomised controlled pivotal trial for FDA then 50% get oncosil in combination with standard of care chemo, the other 50% that make up control arm get the standard of care chemo. You're trying to answer in a controlled setting does giving the osl device adds any benefit over standard of care chemo. It's no different to how other similar devices might run a trial. Nobody is disadvantaged as the control arm patients still getting what is considered best current treatment, so shouldn't be any ethical problems.