Correction: Effects of half-dose spiomet treatment in girls with early puberty and accelerated bone maturation: a multicenter, randomized, placebo-controlled study protocol

Correction: Trials 24, 56 (2023)

https://doi.org/10.1186/s13063-022-07050-w

After publication of the article [1] the authors noticed several errors related to the inclusion and exclusion criteria. The clinical trial registration has been updated and the ethical committee has reviewed the changes.

Incorrect	Correct
Inclusion criteria 1) Age at study start 8.0–9.3 years; 2) BW for gestational age in lower tertile (− 1.96 < Z-score <  − 0.44); 3) BMI for CA in upper tertile (+ 0.44 < Z-score <  + 1.96) [2]; 4) Early progressive puberty [bilateral breast development (Tanner stage 2)] starting between 7.7 and 9.0 years, with a minimum of 4 months of progression) [3, 4]; 5) White ethnicity; 6) Full-term pregnancy: 37 ≤ gestational age < 42 weeks; 7) Height at 1st visit: 3rd percentile ≤ height ≤ 97th percentile; and 8) Written informed consent of parents or legal representative.	Inclusion criteria 1) Age at study start 8.0–9.3 years; 2) BW for gestational age in lower tertile (-2.5 < Z-score < 0); 3) BMI for CA in upper tertile (0 < Z-score <  + 2.5) (2); 4) Early progressive puberty [bilateral breast development (Tanner stage 2)] starting between 7.7- 9.3 years, with a minimum of 2 months of progression) (3,4); 5) White ethnicity; 6) Full-term or late preterm pregnancy: 34 ≤ gestational age < 42 weeks; 7) Height at 1st visit: 3rd percentile ≤ height ≤ 97th percentile (adjusted by pubertal stage); 8) Written informed consent of parents or legal representative.
Exclusion criteria 1) Excessive delay or advance of bone age (more than 2 years for chronological age); 2) Tanner stage of breast development greater than 2; 3) Twin pregnancy; 4) Obesity at 1st visit (BMI Z-score above + 1.96 for chronological age); 5) Evidence for a pathological cause of the rapid maturation (i.e., congenital adrenal hyperplasia due to 21-hydroxylase deficiency); 6) Known genetic abnormality or chronic conditions, including cardiovascular, neurological, immunological, metabolic, renal, endocrine, digestive, respiratory or oncological diseases; 7) Chronic use of medications, among others: anticoagulants, anti-inflammatories, oral hypoglycemic agents, antiandrogens, estrogens, progestins, glucocorticoids, digoxin. Only the use of paracetamol before or during the course of the study will be accepted; 8) Acute infections or intake of antibiotics or anti-inflammatory medication in the last 14 days; 9) Previous history of hypersensitivity to any of the drugs used in the clinical trial, or to its excipients; and 10) Any disease that, in the opinion of the investigator, compromises the inclusion of the subject in the clinical trial.	Exclusion criteria 1) Excessive delay or advance of bone age (more than 2 years for chronological age); 2) Tanner stage of breast development greater than 2; 3) Twin pregnancy; 4) Obesity at 1st visit (BMI Z-score above + 2.5 for chronological age); 5) Evidence for a pathological cause of the rapid maturation (i.e., congenital adrenal hyperplasia due to 21-hydroxylase deficiency); 6) Known genetic abnormality or chronic conditions, including cardiovascular, neurological, immunological, metabolic, renal, endocrine, digestive, respiratory or oncological diseases; 7) Chronic use of medications, among others: anticoagulants, anti-inflammatories, oral hypoglycemic agents, antiandrogens, oestrogens, progestins, glucocorticoids, digoxin. Only the use of paracetamol before or during the course of the study will be accepted; 8) Acute infections or intake of antibiotics or anti-inflammatory medication in the last 14 days; 9) Previous history of hypersensitivity to any of the drugs used in the clinical trial, or to its excipients; 10) Any disease that, in the opinion of the investigator, compromises the inclusion of the subject in the clinical trial.