Cluster 649: uncontrolled diabetes hypertension days prior randomization assessment toxicity conditions interfere Cluster 1324: severe intercurrent infection sepsis patients medical infusion procurement acute conditions Cluster 1638: conditions cardiac medical following affect impose study compliance opinion comorbid Cluster 1812: conditions medical interfere uncontrolled psychiatric treatment severe participation affect study Cluster 2283: preclude disorder participation medical outlined uncontrolled psychiatric active geographic adherence