Fig. 1: CONSORT 2010 flow diagram — adapted for AI clinical trials.

CONSORT-AI 4a (i): State the inclusion and exclusion criteria at the level of participants. CONSORT-AI 4a (ii): State the inclusion and exclusion criteria at the level of the input data. CONSORT 13b (core CONSORT item): For each group, losses and exclusions after randomization, together with reasons.