| Outcome Measures: |
Primary: Number of Participants With First Occurrence of Any Serious Vascular Event (SVE), The primary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 fatty acids versus placebo on the first occurrence of any "Serious Vascular Event" (SVE), defined as: * non-fatal myocardial infarction; or * non-fatal stroke (excluding confirmed intracranial hemorrhage) or TIA; or * vascular death excluding confirmed intracranial hemorrhage (defined as International Classification of Diseases 10th revision \[ICD-10\] I00-52 or I63-99, i.e. excluding subarachnoid hemorrhage \[I60\], intracerebral hemorrhage \[I61\], and other non-traumatic intracranial hemorrhage \[I62\])., Randomized treatment phase during a mean of 7.4 years|Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only), The primary safety assessments involve intention-to-treat comparisons among all randomized patients of allocation to aspirin versus placebo on the first occurrence of "any major bleed", defined as: * any confirmed intracranial hemorrhage (including intracerebral, subarachnoid, subdural or any other intracranial hemorrhage); or * sight-threatening eye bleeding; or * any other serious bleeding episode., Randomized treatment phase during a mean of 7.4 years | Secondary: Number of Participants With Combined End-point of Serious Vascular Events (SVEs) or Revascularizations, Secondary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 versus placebo on the first occurrence of the expanded vascular endpoint of "SVE or revascularization" (including coronary and non-coronary revascularizations)., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Any Incident Gastrointestinal (GI) Tract Cancer (Aspirin Comparison Only), Secondary efficacy assessments of aspirin involve intention-to-treat comparisons during the scheduled treatment period among all randomized participants on the first occurrence of: Any incident gastrointestinal (GI) tract cancer (i.e. any GI cancer excluding pancreas and hepatobiliary), overall and after exclusion of the first three years of follow-up., Randomized treatment phase during a mean of 7.4 years | Other: Number of Participants With Fatal Event: All-cause Mortality, 'All-cause mortality' includes all recorded deaths., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Fatal Event: Coronary, Fatal 'Coronary' events include deaths from: Acute MI and other CHD (unspecified Acute ischaemic heart disease; Atherosclerotic heart disease; Ischaemic cardiomyopathy; unspecified Chronic ischaemic heart disease)., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Fatal Event: All Stroke, Fatal 'All stroke' events include deaths from: Haemorrhagic stroke (Intracerebral haemorrhage; Subarachnoid haemorrhage); Non-haemorrhagic stroke (Cerebral infarction; Stroke not specified as haemorrhage or infarction)., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Fatal Event: Other Vascular, Fatal 'Other vascular' events include deaths from: Heart failure (excluding ischaemic cardiomyopathy); Other vascular death (excluding stroke; and Cardiac death (excluding CHD)., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Fatal Event: Cancer, Fatal 'Cancer' events include any death attributed to cancer., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Fatal Event: Respiratory, Fatal 'Respiratory' events include any death attributed to respiratory causes., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Fatal Event: Other Medical, Fatal 'Other medical' events include deaths from: Non-vascular medical causes (excluding cancer and respiratory, including Fatal GI bleed or perforation); and deaths from Renal disease and Diabetes., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Fatal Event: External Cause, Fatal 'External cause' events include deaths from: Injury; Fracture; Self harm; and Medical and surgical complications, Randomized treatment phase during a mean of 7.4 years|Number of Participants With Fatal Event: Unknown Cause, Any death for which the cause is not known., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Event: Any Cancer, Incidence of fatal or non-fatal cancers. Any cancer excludes non-fatal non-melanoma skin cancer and non-fatal recurrence of a cancer that had occurred before randomization. A single participant may have had multiple cancers., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Event: Other Gastrointestinal Cancer (Aspirin Comparison Only), Includes fatal and non-fatal cancers. Excludes cancers reported in the gastrointestinal tract category (see secondary outcome measure #4), and includes hepatobiliary and pancreatic cancers., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Event: Respiratory Cancer, Includes fatal and non-fatal cancers. Includes lung and larynx cancer., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Event: Genitourinary Cancer, Includes fatal and non-fatal renal, bladder, prostate, gynaecological and other GU cancers, Randomized treatment phase during a mean of 7.4 years|Number of Participants With Event: Hematological Cancer, Includes fatal and non-fatal cancers. Includes leukaemia and lymphoma., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Event: Breast Cancer, Includes fatal and non-fatal cancers., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Event: Melanoma, Includes fatal and non-fatal melanomas., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Event: Other Cancer, Includes fatal and non-fatal cancers not included elsewhere (where the type of cancer is known)., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Event: Unspecified Cancer, Includes fatal and non-fatal cancers of unknown type., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Event: Atrial Fibrillation (Omega-3 Comparison Only), Includes fatal and non-fatal events., Randomized treatment phase during a mean of 7.4 years|Number of Participants With Event: Other Arrhythmia (Omega-3 Comparison Only), Includes fatal and non-fatal events, excludes atrial fibrillation., Randomized treatment phase during a mean of 7.4 years
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