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Hayashi D, Edwards C, Emond JA, Gilbert-Diamond D, Butt M, Rigby A, Masterson TD

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An investigational medicine is being studied so that researchers and regulators can assess questions such as: Whether it produces the intended effect Which adverse events occur How frequently those events occur Whether the potential benefits outweigh the known risks How it should be manufactured and quality controlled Which patients, if any, might be suitable for an authorised use Whether additional long term evidence is needed Passing through one clinical trial phase does not guarantee success in the next