; or (B) strategies that will be used to enroll and retain participants across the different race, ethnicity, age, and sex categories; (3) a detailed plan for how the clinical trial will achieve the goals specified under paragraph (1) that specifies— (A) the requirements for researchers, in conducting the trial, to analyze the population groups specified in paragraph (1) separately; and (B) how the trial will recruit a study population that is— (i) scientifically and ethically appropriate in terms of the scientific objectives and proposed study design; and (ii) in sufficient numbers to obtain clinically and statistically meaningful determinations of the safety and effectiveness of the drug, device, or behavioral intervention being studied in the respective race, ethnicity, age, and sex groups; and (4) the NIH-funded research organization or entity’s plan for implementing, or an explanation of why the NIH-funded research organization or entity cannot implement, alternative clinical trial follow-up requirements that are less burdensome for trial participants, such as— (A) requiring fewer follow-up visits; (B) allowing phone follow-up or home visits by appropriately qualified staff (in lieu of in-person visits by patients); (C) allowing for online follow-up options; (D) permitting the patient’s primary care provider to perform some of the follow-up visit requirements; (E) allowing for evening and weekend hours for required follow-up visits; (F) allowing virtual or telemedicine visits; (G) use of wearable technology to record key health parameters