Outcomes (CONSORT diagram).
For comparison of the primary outcome between the two treatment arms in this trial we carried out three types of analysis: First, in the intention to treat analysis (ITT) of all 387 participants, 46 of 195 patients (23.6%) randomized to SoC reached the primary outcome compared to 31 of 192 patients (16.1%) randomized to SoC+Doxy (OR 0.617, 95% CI 0.369 to 1.027, p = 0.063) (