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Phase Main aims of trial 1 Determination of side effects and maximum absorbed doses to regions at risk (absorbed-dose ranging) 2 Refinement of optimal absorbed doses to target regions and regions at risk, to balance treatment efficacy with risks of side effects 3 Comparison of treatment effectiveness and safety against standard of care, at therapeutic absorbed doses defined in previous trials 4 Postmarketing surveillance in public, to monitor long-term effects after administration of therapeutic absorbed doses