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Registrants must always submit their information within the framework of a joint submission. However, registrants can submit some information separately, if:
- it would be disproportionately costly for them to submit some information jointly, or
- submitting the information jointly would lead to the disclosure of commercially sensitive information that would likely cause substantial commercial detriment, or
- they disagree with the lead registrant on the selection of information.
Registrants who fall under any of the above circumstances can submit some or all data on their own: these are respectively called partial and full opt-out. Technical implementation of the opt-out is described in Q&A 396.