This was because post hoc subgroup analyses showed an

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Fifteen minutes sitting together working from a shared large print book. A further 15 minutes focusing on certain words with the class. Twenty minutes devoted to reading or writing on their own or in small groups. This restriction may relate to the safety concerns of regulatory agencies or to the need to maximise the benefit risk ratio in the approved indication. For example, the indication for rilpivirine in patients with HIV was restricted to those with a viral load of 100000 HIV 1 RNA copies/mL. This was because post hoc subgroup analyses showed an increased risk of resistance and a lower virological response rate with rilpivirine in patients with a high baseline viral load (>100000 copies/mL).19 Clinical studies in which a drug was used outside the scope of the approved patient population may overestimate or underestimate a drug’s benefit or harm.

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