We describe the statistical analysis plan ( SAP ) for the Permissive Hyperthermia through Avoidance of Paracetamol in Known or Suspected Infection in the Intensive Care Unit ( HEAT ) trial , a 700-patient , prospective , randomised , Phase 2b , multicentre , double-blind , parallel-groups , placebo-controlled trial of paracetamol administration for the treatment of fever in critically ill patients with known or suspected infection .