- •The majority of patients on maintenance placebo experienced adverse events (AEs).
- •AEs were associated with dose delays, reductions and discontinuation of placebo.
- •The underlying aetiology is complex and likely involves the nocebo phenomenon.
- •AEs in randomised trials may not reflect true investigational treatment toxicities.
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☆This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.