Fig. 1.

SMILE total population CONSORT diagram. ⁺ One participant was ineligible due to interruption in recruitment due to EVG withdrawal off the market. One participant was ineligible due to viral resistance to Darunavir. ∗ 5 participants in each arm were randomised before temporary suspension due to EVG withdrawal from the market. ∗∗ During the COVID-19 pandemic, sites were advised they could conduct follow-up visits by phone if there was an additional risk to come in person. Eight participants missed the trial endpoint visit at week 48 (7 in INSTI + DRV/r; 1 in SOC); 5 out of the 8 participants came in 1–6 days late and missed week 48 max window (fell in week 60 window), 3 participants missed week 48 clinic visit/telephone follow-up.