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However, pharmacovigilance reporting in public databases is subject to many major limitations, such as heterogeneous reporting, including notoriety and ripple bias, double reporting, the lack of a population denominator or enough clinical detail to enable comparison between agents and over time [20, 22], therefore no causal association link can be inferred from such studies

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This has been established in trials in adult patients with chronic low back pain and chronic pain due to osteoarthritis

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