Table 5 Assessments during the study visits in the randomized clinical trials (RCTs)

Study visits

Baseline visit 1

Visit 2

Visit 3

Visit 4; end of trial (EOT)

Visit 5; test of cure

Time points

Day 0–1

Day 8 (±2 days)

Day 15 (±2 days)

Day 21 (±2 days)

20–30 days after EOT

Identity; MRI examination

x

Inclusion/exclusion criteria

x

x

Informed consent

x

Demographics

x

Medical history

x

x

Clinical assessment of infection

x

x

x

x

x

Intraoperative sampling

x

Control of compliance

x

x

x

x

Adverse events

x

x

x

Study end (control)

x

Study visits

Baseline visit 1

Visit 2

Visit 3

Visit 4

Visit 5; end of trial (EOT)

Visit 6; test of cure

Time points

Day 0–1

Day 8 (±2 days)

Day 15 (±2 days)

Day 21 (±2 days)

Day 40 (±2 days)

20–30 days after EOT

Identity; MRI examination

x

x

x

x

x

x

Inclusion/exclusion criteria

x

x

Informed consent

x

Demographics

x

Medical history

x

x

Clinical assessment of infection

x

x

x

x

x

x

Intraoperative sampling

x

Control of compliance

x

x

x

x

x

Adverse events

x

x

x

x

x

Study end (control)

x