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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