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"To approve a treatment that helps people to stay alive longer...

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    "To approve a treatment that helps people to stay alive longer and / or increase their quality of live one has to demonstrate safety and efficacy in endless trials. "

    The history of medicine is riddled with many treatments that seemed like they were good ideas at the time but were eventually proven to be useless or worse, actually harmful.

    Thus, the seemingly ridiculous number of trials.
 
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