Adjuvant melatonin for uveal melanoma (AMUM): protocol for a randomized open-label phase III study

Table 2 Flowchart

Time	Screening − 30 days before 1 m visit	Month 1 ± 7 days	Month 6 ± 4 weeks	Year 1 ± 4 weeks	Year 1.5 ± 8 weeks	Year 2 ± 8 weeks	Year 2.5 ± 8 weeks	Year 3 ± 8 weeks	Year 3.5 ± 8 weeks	Year 4 ± 8 weeks	Year 4.5 ± 8 weeks	Year 5 ± 8 weeks
Inclusion/exclusion	x
Informed consent	x
Randomization melatonin/control group	x
Medical history, current medication	x
Medication instruction	x
Radiological examination—liver			x	x	x	x	x	x	x	x	x	x
Radiological examination—thorax and abdomen	x
Blood samples	x					x				x
AE and SAE, prescription compliance		x	x	x	x	x	x	x	x	x	x	x
End of study												x

ISSN: 1745-6215