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Table 1 Overview of in- and exclusion criteria for the AGAINST-PLD study

From: Protocol for a randomized controlled multicenter trial assessing the efficacy of leuprorelin for severe polycystic liver disease: the AGAINST-PLD study

Inclusion criteria  
 Female  
 Diagnosis of PLD (presence of > 10 cysts)  
 Age 18–45 (inclusive) years  
 Very large liver for age:  
  18–30 y hTLV > 2.0 L/m  
  30–35 y hTLV > 2.2 L/m  
  25–40 y hTLV > 2.5 L/m  
  40–45 y hTLV > 3.0 L/m  
 1 historical MRI or CT scan of the liver available, made 5-1 y before baseline  
 Ongoing liver growth, confirmed using the historical scan and MRI scan at screening  
 Use of somatostatin analogues OR a reason not to use them (e.g. tried in de past but stopped because of side effects, not effective, no acces, patient does not want to)  
 Voluntary written informed consent  
Exclusion criteria  
 Post menopausal status or (vasomotor) symptoms indicating upcoming menopause  
 AMH < 0.03 ng/ml at screening  
 Active desire to have children, pregnancy or breast-feeding  
 Contra-indications for leuprorelin, such as cardiovascular disease or osteoporosis  
 Liver transplantation expected within 1.5 years  
 Use of oral estrogen or progesterone containing medication  
 Contra-indications for MRI  
 Chronic use of immunosupressive agents  
 Severe hypertension (systolic pressure ≥ 160 and/or diastolic pressure ≥ 100 mmHg)  
 Clinically significant uncontrolled medical condition that, in the opinion of the investigator, would put the safety of the patient at risk though participation, or which would affect efficacy or safety analysis, such as, but not limited to, recurrent cholangitis, recurrent ascites, hepato-venous outflow obstruction, (history of) depression  
 Participation in other interventional studies at the same time  
Exclusion criteria related to the historical MRI/CT scan  
 Start or stop of liver volume reducing therapy (medication e.g. somatostain analogues or surgical interventions) between the historical scan and screening  
 Historical scan is performed < 3 months after start or stop of volume reducing therapy (either a somatostatin analogue or surgical treatments)