Here is the design of a clinical trial:

Official Title: Evaluation of the Efficacy of an inTerdialytic "Ethanol 40% v/v - enoxapaRin 1000 U/mL" Lock solutioN to Prevent Tunnelled Catheter Infections in Chronic Hemodialysis Patients: a mulTi-centre, Randomized, Single Blind, Parallel Group studY (ETERNITY)

Included conditions:
- Tunnelled Hemodialysis Catheter Infection

Study Armgroups:
- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Enrolled patients will be randomly assigned in a 1:1 ratio either to the intervention group (Ethenox) or to the control group (reference solution: UFH 5000 U/mL or citrate 4% w/v depending on which solution is generally used).', 'interventionNames': ['Drug: Ethanol']}
- {'label': 'control group', 'type': 'OTHER', 'description': 'Enrolled patients will be randomly assigned in a 1:1 ratio either to the intervention group (Ethenox) or to the control group (reference solution: UFH 5000 U/mL or citrate 4% w/v depending on which solution is generally used).', 'interventionNames': ['Drug: enoxaparin']}

Interventions:
- {'type': 'DRUG', 'name': 'Ethanol', 'description': 'An ethanol 40 % v/v - enoxaparin 1000 U/mL (Ethenox) interdialytic lock solution', 'armGroupLabels': ['Intervention group']}
- {'type': 'DRUG', 'name': 'enoxaparin', 'description': 'An ethanol 40 % v/v - enoxaparin 1000 U/mL (Ethenox) interdialytic lock solution', 'armGroupLabels': ['control group']}

Primary Outcomes:
- {'measure': 'Time to first TC infection (TCI)', 'description': 'TCI is a composite endpoint defined by the occurrence of at least one of the three following events:\n\nDefinitive TC-related bloodstream infection (definitive TCBSI) or Probable TC-related bloodstream infection (probable TCBSI) or TC exit-site infection (ESI). TCI diagnosis and its type (definitive or probable TCBSI or ESI) will be assessed by an endpoint adjudication committee (EAC) according to predefined criteria', 'timeFrame': 'at 1 year'}

Please estimate the sample size based on the assumption: 
Statistical power of 90%, type I error risk of 5%, enrollment period of 24 months.
Sample size calculation
        The working hypothesis of this randomized controlled trial is that Ethenox will double the median time to TCI. On the basis of the data collected in DIALIN, median TC duration use is 6âmonths [29]. The median survival time without TCI reported in recent clinical trials ranges between 690 and 1150âdays. However, to achieve a statistical power of 90% with a risk of type I error of 5%, a total of 400 patients need to be enrolled over a period of 24âmonths.