Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.

Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 g/L (2 g/dL), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular).

Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.

Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences.

Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.

Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers.

Intent to treat (ITT) population included all participants who were enrolled into the study.

Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs.

ITT population included all participants who were enrolled into the study.

A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.

ITT population included all participants who were enrolled into the study.

Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.

The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.

The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.

MCVE were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.

The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.

The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant's pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.

ITT population included all participants who were enrolled into the study.

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

ITT population included all participants who were enrolled into the study. This was calculated only when more than half of the questions within dimension were answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.