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Table 2 PATH-2 inclusion and exclusion criteria

From: Platelet-rich plasma in Achilles tendon healing 2 (PATH-2) trial: statistical analysis plan for a multicentre, double-blinded, parallel-group, placebo-controlled randomised clinical trial

Inclusion criteria Exclusion criteria
• Acute Achilles tendon rupture
• 18+ years of age
• Presenting and receiving treatment within 12 days after injury
• Referred to non-operative treatment
• Ambulatory prior to injury without the use of walking aids or assistance
• Willing to give informed consent and able to comply with all study requirements
• Achilles tendon injuries at the insertion to the calcaneum or at the musculo-tendinous junction
• Previous major tendon or ankle injury or deformity to either lower leg
• History of diabetes mellitus
• Known platelet abnormality or haematological disorder
• Current use of systemic cortisone or treated with anticoagulant
• Evidence of lower limb gangrene/ulcers or peripheral vascular disease
• History of hepatic or renal impairment or dialysis
• Pregnant or breast feeding
• Having received radiation or chemotherapy within the last 3 months
• With inadequate venous access for drawing blood
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk or influence study results