Here is the design of a clinical trial:

Official Title: Transmyringeal Ventilation Tube Insertion for Unilateral Menière's Disease: a Prospective, Sham-controlled, Double-blinded, Randomized, Clinical Trial

Included conditions:
- Meniere Disease

Study Armgroups:
- {'label': 'Ventilation tube insertion', 'type': 'EXPERIMENTAL', 'description': 'Ventilation tube insertion into the tympanic membrane.', 'interventionNames': ['Procedure: Transmyringeal ventilation tube insertion']}
- {'label': 'Sham-treatment', 'type': 'SHAM_COMPARATOR', 'description': 'Sham-treatment. Manipulation of the tympanic membrane to simulate ventilation tube insertion without performing a ventilation tube insertion.', 'interventionNames': ['Procedure: Sham-treatment']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Transmyringeal ventilation tube insertion', 'description': 'In both groups, the tympanic membrane will be anesthetized by local application of topical prilocaine (EMLA) or phenol or by infiltration anaesthesia of the outer ear canal. The choice of method is left to the discretion of the surgeon.\n\nFor the experimental group, insertion of a ventilation tube will be performed. An incision is performed, usually in the lower, anterior quadrant of the tympanic membrane and the transmyringeal tube is inserted.', 'armGroupLabels': ['Ventilation tube insertion'], 'otherNames': ['Ventilation tube insertion, grommet insertion']}
- {'type': 'PROCEDURE', 'name': 'Sham-treatment', 'description': 'For the control group, the ENT-specialist will touch the tympanic membrane with an alligator ear forceps to simulate getting a paracentesis. In the same procedure, without having made a paracentesis, a ventilation tube is placed on the tympanic membrane and removed again afterwards. The reason for the above-mentioned is to simulate getting a paracentesis and insertion of a ventilation tube.', 'armGroupLabels': ['Sham-treatment']}

Primary Outcomes:
- {'measure': 'Number of vertigo attacks lasting more than 20 minutes', 'description': 'Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire.', 'timeFrame': '3 months'}
- {'measure': 'Number of vertigo attacks lasting more than 20 minutes', 'description': 'Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire.', 'timeFrame': '24 months'}

Please estimate the sample size based on the assumption: 
Not explicitly stated in the provided paragraph.
Sample size
        The primary outcome in the study will be the number of attacks within the first 3 months after ventilation tube insertion. Because this is count data (i.e. an incidence rate) a Poisson distribution is expected, and a Poisson regression model most likely will give the best fit for analysis of the primary outcome.
        The simulation software âPowersimâ developed for the used statistical package, STATA, was applied for Power calculations.
        Given the lack of published data concerning the expected effect of ventilation tube insertion, we chose to assume a 50% reduction in the intervention group, which we believe is realistic as well as a necessity. A 50% reduction gives an Incidence Rate Ratio (IRR) of 0.5 and an ln(IRR) of â0.69315.
        Using an alpha value of 0.05 and an expected effect size of 0.5 (ln(0.5) = â0.69315), and to obtain a power of 0.8, an expected 94 participants in total or 47 participants in each group will be necessary. To adjust for drop-outs, a safety margin of 10% results in 104 participants in total.