a Nationwide PEM.

* there are related drugs with significant problems;

* the target disease is of low risk and any increased risk arising from therapy would adversely affect the benefit-risk balance;

* safe treatment options are already available and any increase in risk would be unacceptable;

* another drug of the same class is being monitored or considered, which provides the added value of a comparator and also raises the question of equity for the sponsors.

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