Table 2.

Study procedures and measures.

Action	Inclusiona	PDT 1b	PDT 2c	Evaluation M3d	PDT 3e	PDT 4f	Evaluation M6g
Informed consent	x
Medical examination	x	x	x	x	x	x	x
Selection criteria	x
Photographs of lesions under natural light	x	x	x	x	x	x	x
Biopsy	x			x			x
HCGh pregnancy test		x	x		x	x
Erythema gradation	x			x			x
Erythema measurement with CR-400 Chroma Meter	x			x			x
DLQIi, FSFIj, SF-36k, and HADSl questionnaires	x			x			x
Application and incubation of Metvixia		x	x		x	x
Illumination process		x	x		x	x
Photographs of lesions under fluorescent light		x	x		x	x
VASm measurement of pain		x	x		x	x
Evaluation of tolerance/AEn/SAEo		x	x	x	x	x	x
Patient satisfaction							x

^aInclusion: D0.

^bPDT 1: photodynamic therapy within 30 days or at D0.

^cPDT 2: photodynamic therapy 15 days after PDT 1 (±2 days).

^dEvaluation M3: D0 + 3 months (± 7 days).

^ePDT 3 (optional): photodynamic therapy within 30 days after M3.

^fPDT 4 (optional): photodynamic therapy 15 days after PDT 3 (±2 days).

^gEvaluation M6: D0 + 6 months (±7 days).

^hHCG: human chorionic gonadotropin test.

ⁱDLQI: Dermatology Life Quality Index.

^jFSFI: Female Sexual Functioning Index.

^kSF-36: 36-item Short Form Health Survey.

^lHADS: Hospital Anxiety and Depression Scale.

^mVAS: visual analog scale.

ⁿAE: adverse events.

^oSAE: serious adverse events.