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Serraj, J

Several commenters maintained that it would be difficult to only use EDI 835 ERA transaction data to calculate and encode the allowed amounts because the data is not standardized, the data may not capture item or service level detail, payers use claim adjustment reason codes (CARC) and remittance advice reason codes (RARC) inconsistently, and payers frequently deviate from Health Insurance Portability and Accountability Act (HIPAA) standard transaction requirements

The diaries offered eight possibilities to be checked by the patients each hour of the day between sleep, dyskinesia (severe, moderate, mild), off period (severe, moderate, mild) and on without dyskinesia period (Supplementary Home Diary)

After one-third of the study participants have been enrolled and completed follow-up, the DSMBs will review the data and make recommendations concerning continuation, modification or termination of the study due to unexpectedly large beneficial effects or serious side effects and can suggest extension of the trial should the primary outcomes occur less often than anticipated