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In general, there are five criteria that must be met to establish a cause and effect relationship. These are:

Strength of association: Power and sample size must be sufficient to demonstrate a statistically significant difference.

Consistency: Observation of the association must be repeatable in different populations at different times.

Temporality: The cause must precede the effect.

Plausibility: The explanation must be biologically plausible.

Biological gradient: The presence of a dose-response relationship.