Randomisation, controlling and masking
Participants were randomly assigned to PDT or placebo group (1:1). The investigator who performed randomization did not apply treatments nor collected biological samples. Participants and investigators assessing outcomes were masked to group assignment.The control treatment was performed using saline solution and a sham treatment with a switched-off laser illuminator device, with the patient blinded to the intervention by polarizing glasses. Placebo-treated participants followed the same timing and cycle protocol as the PDT- group.