Study design and participants
SECONDARY
This is an exploratory analysis of the secondary objective in the KARISMA trial (assess the level of side effects at lower doses and compare to the 20 mg arm), the analyses are thereby not predefined in the protocol. The full study protocol can be found elsewhere [The KARISMA trial (EudraCT: 2016-000882-22) is an investigator-initiated, double-blind, randomised placebo-controlled six-armed dose-determination trial conducted in Sweden between 2016 and 2019 [