Limitations
SECONDARY
Our study has several limitations. First, as in any unmasked procedure‐based interventional trial, knowledge of the treatment assignment may introduce biases that affect both what patients report in their QOL surveys and what their managing clinicians choose to do in response to their clinical course during trial follow‐up. Second, the repeated measures nature of QOL assessment together generates a large number of potential outcome comparisons, and a sex subgroup analysis effectively doubles that number. As reported previously, we addressed this issue for the trial overall by prespecifying 2 coprimary QOL measures (AFEQT and MAFSI) and 1 primary time point (12 months) with all other comparisons considered secondary and supportive.