Here is the design of a clinical trial:

Official Title: A Naturalistic Study Comparing Uni- and Bi-lateral Theta Burst Stimulation in Major Depression

Included conditions:
- Major Depressive Episode

Study Armgroups:
- {'label': 'Unilateral TBS', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC. Realistic sham continuous TBS (cTBS-sham) will be applied to the right DLPFC. Participants will receive daily sessions (Mon-Fri) for 4 to 6 weeks (stop at 4 weeks if remission is achieved).', 'interventionNames': ['Device: Theta burst stimulation']}
- {'label': 'Bilateral TBS', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC and continuous TBS (cTBS) will be applied to the right DLPFC. Participants will receive daily sessions (Mon-Fri) for 4 to 6 weeks (stop at 4 weeks if remission is achieved).', 'interventionNames': ['Device: Theta burst stimulation']}
- {'label': 'Maintenance Phase: Flexible', 'type': 'ACTIVE_COMPARATOR', 'description': 'The flexible maintenance protocol will be based on symptom emergence. Participants will receive a fixed TBS (2x/week) schedule for the first month. For the following months (2-6), they will come in for an assessment (HRSD-17) to determine how many TBS sessions (0, 1, or 2) they receive on a flexible basis.', 'interventionNames': ['Device: Theta burst stimulation']}

Interventions:
- {'type': 'DEVICE', 'name': 'Theta burst stimulation', 'description': 'Cool B70 coil (left DLPFC) and Cool B65 active/placebo coil (right DLPFC), with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)', 'armGroupLabels': ['Bilateral TBS', 'Maintenance Phase: Flexible', 'Unilateral TBS']}

Primary Outcomes:
- {'measure': 'Response - Treatment Phase (Hamilton Rating Scale for Depression-17 score)', 'description': 'Response to treatment will be defined as a \\> 50% reduction in pre-treatment symptoms severity as measured by the mean Hamilton Rating Scale for Depression-17 score. The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.', 'timeFrame': 'Week 6'}
- {'measure': 'Remission - Treatment Phase (Hamilton Rating Scale for Depression-17 Score)', 'description': 'Remission will be defined as a Hamilton Rating Scale for Depression-17 score ≤ 8 The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.', 'timeFrame': 'End of treatment phase (week 4 or 6)'}
- {'measure': 'Response - Maintenance Phase (Hamilton Rating Scale for Depression-17 score)', 'description': 'Response to treatment will be defined as a \\> 50% reduction in pre-treatment symptoms severity as measured by the mean Hamilton Rating Scale for Depression-17 score. The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome', 'timeFrame': '6 months'}
- {'measure': 'Remission - Maintenance Phase (Hamilton Rating Scale for Depression-17 Score)', 'description': 'Remission will be defined as a Hamilton Rating Scale for Depression-17 score ≤ 8 The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.', 'timeFrame': '6 months'}

Please estimate the sample size based on the assumption: 
Power = 0.80, significance level (α) = 0.05, anticipated dropout rate = 6-8%.
Sample size
        Based on our power calculations and the findings from exemplary studies, our sample size offers sufficient statistical power for the planned statistical tests. For example, Plewnia et al. (2014), in nâ=â32 (16/group), found clinically meaningful differences in response to treatment rate (â¥â50% reduction in baseline MADRS score) when comparing 6Â weeks of bilateral sequential vs sham TBS (56% vs 25%, respectively) [42]. In nâ=â60 (15/group), Li et al. (2014) showed that 2Â weeks of bilateral sequential TBS had superior effectiveness in treating depressive symptoms (â¥â50% reduction in baseline HRSD-17 score) when compared to unilateral (iTBS or cTBS) or sham TBS [106]. For our primary (non-inferiority) statistical analysis (i.e., analysis of covariance, ANCOVA), a total sample size of nâ=â158 was calculated [Gpower Software V.3.1 [107]; power 0.80, Î±â=â0.05, expected effect size Cohenâs fâ=â0.25 (medium; Cohen, 1988)]. For our analysis of predictors of response (i.e., regression analysis), a total sample size of nâ=â30â39 will be required for a regression model that includes 3â6 independent (and/or controlling) variables predicting 30% (R2) of variance in the outcome (dependent) variable (Gpower Software V.3.1 [107]; power 0.80, Î±â=â0.05, expected effect size Cohenâs f2â=â0.43) [108]. All other statistical tests are exploratory and, therefore, no sample size calculations were performed. Therefore, in order to achieve the calculated sample size (nâ=â158), we aim to recruit a minimum of 171 individuals, considering an anticipated dropout rate of 6â8% based on previous research [37]. Our recruitment efforts will be capped at a maximum of 256 participants, aligning with our capacity to provide TBS treatment over a five-year timeframe.